title: Use of a serotonin re-uptake inhibitor, fluoxetine, in the treatment of obesity. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews An open-label pilot study of the combination therapy of metformin and fluoxetine for weight reduction Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial. Fluoxetine increases resting energy expenditure and basal body temperature in humans. Fluoxetine's effect on weight loss in obese subjects. Designing psycho-oncology randomised trials and cluster randomised trials: variance components and intra-cluster correlation of commonly used psychosocial measures. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials The effects of fluoxetine combined with nicotine inhalers in smoking cessation--a randomized trial. [Effectiveness of serotonergic agonists in the treatment of obese patients]. Comparison of registered and published primary outcomes in randomized controlled trials. Use of fluoxetine, a selective serotonin-uptake inhibitor, in the treatment of obesity: a dose-response study (with a commentary by Michael Weintraub). A checklist designed to aid consistency and reproducibility of GRADE assessments: development and pilot validation Efficacy and safety of long-term fluoxetine treatment of obesity--maximizing success. Fluoxetine: relationships among dose, response, adverse events, and plasma concentrations in the treatment of depression. A comparative study of five centrally acting drugs on the pharmacological treatment of obesity Double-blind placebo-controlled trial of fluoxetine in smoking cessation treatment including nicotine patch and cognitive-behavioral group therapy. Fluoxetine: a randomized clinical trial in the maintenance of weight loss. A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients. No specific effect of fluoxetine treatment on fasting glucose, insulin, lipid levels, and blood pressure in healthy men with abdominal obesity. Changes in weight during a 1-year trial of fluoxetine. Effect of fluoxetine on weight reduction in obese patients What constitutes an adequate antidepressant trial for fluoxetine? The effect of the 5-HT re-uptake inhibitor fluoxetine on food intake and body weight in healthy male subjects. Assessing baseline imbalance in randomised trials: implications for the Cochrane risk of bias tool. Effects of fluoxetine and melatonin on mood, sleep quality and body mass index in postmenopausal women. Weight gain during long-term treatment of obsessive-compulsive disorder: a prospective comparison between serotonin reuptake inhibitors. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance phases. Serotoninergic manipulation, meal-induced satiety and eating pattern: effect of fluoxetine in obese female subjects. Fluoxetine in medically stable, depressed geriatric patients: effects on weight. Obesity among outpatients with major depressive disorder. The addition of dexfenfluramine to fluoxetine in the treatment of obesity: a randomized clinical trial. Predictors of response to amine-specific antidepressants. Multicenter trial of fluoxetine as an adjunct to behavioral smoking cessation treatment. Influence of fluoxetine on positive and negative affect in a clinic-based smoking cessation trial Effect of serotonin re-uptake inhibition by fluoxetine on body weight and spontaneous food choice in obesity. Weight suppression and weight rebound in ex-smokers treated with fluoxetine. Optimal length of continuation therapy in depression: a prospective assessment during long-term fluoxetine treatment. Fluoxetine Versus Trazodone in Depressed Geriatric Patients Comparison of fluoxetine and placebo in the treatment of obesity.
abstract: Health risks associated with obesity are well known and compliance with st and ard regimens for weight reduction is frequently unsatisfactory . Fluoxetine is a specific inhibitor of serotonin re-uptake with very minimal affinity for serotonergic or other receptors . It causes a decrement in food intake in animals . Placebo or fluoxetine was given for up to 8 weeks to non-depressed , otherwise healthy , obese patients given minimal dietary advice . Patients given fluoxetine  lost 4.5 + /- 4.0 kg , significantly more than those receiving placebo , 1.4 + /- 0.1 kg . The weight loss was correlated with the degree of obesity in the  fluoxetine-treated patients .  Asthenia was the only event reported significantly more frequently by fluoxetine-treated patients ( 23 percent ) than by those treated with placebo ( 3 percent ) ( P less than 0.01 ) . Fluoxetine appears to be safe and effective in inducing weight loss over periods of up to 8 weeks Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Background : Obesity is a very important risk factor for cardiovascular disease , type 2 diabetes mellitus , hypertension , osteoarthritis , fatty liver , metabolic syndrome and respiratory problems . Many weight-reducing drugs can not be used in obese patients because of numerous complications . Fluoxetine , an antidepressant , and metformin , an antidiabetic drug , reduce weight as their side effect , but the potency of each drug is not always enough . Here , we studied the effects of combination therapy of them for weight reduction in obese women . Material s and methods : This study was design ed as an open , prospect i ve , controlled clinical trial . Obese and overweight patients referred to obesity clinics were first put under a diet and behavior therapy education program before being invited to this study . The patients who accepted drug therapy were put in the case group . Those who did not accept drug therapy were put in the control group . Fluoxetine , 20 mg daily , and metformin , 500 mg three times daily , were prescribed to the participants . Weight and body mass index ( BMI ) changes within case and control groups were analyzed by paired t-tests and between groups by t-testing . Side effects were evaluated by interview and question naire . Subjects : Two hundred and three patients were referred to obesity clinics . Of these , 177 were female with 91 being volunteers for this study . Of this 91 , 66 were in the case group and 25 in the control group . Results : In a 6.68-month period , a 7.89 kg decrease in weight ( 9.32 % ) and a 3.43 U decrease in BMI ( 10.14 % ) were observed in participants of the case group that was statistically significant ( P<0.0001 ) . The participants of the control group were followed for a mean period of 8.12 months . In this period , the participants of the control group showed a 0.48 kg decrease in weight ( 0.52 % ) and a 0.11 U decrease in BMI ( 0.42 % ) . This was not significant . No serious side effects of the drugs were observed in the case group . Conclusion : This open-label pilot study of combination therapy of metformin and fluoxetine gave encouraging weight reduction , and these results suggest the need for a r and omized double-blind clinical trial comparing the two components and the combination to placebo PURPOSE We aim ed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstract s of r and omized controlled trials ( RCTs ) in the field of cancer . METHODS We performed a two-arm , parallel-group RCT . We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion . Two versions of these abstract s were used-the original with spin and a rewritten version without spin . Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and review ers of French national grants . The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) . Participants were blinded to study hypothesis . RESULTS Three hundred clinicians were r and omly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin . For abstract s with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) . There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial . CONCLUSION Spin in abstract s can have an impact on clinicians ' interpretation of the trial results Humans lose weight when administered fluoxetine , an inhibitor of serotonin reuptake by nerve terminals . To determine whether increased energy expenditure contributes to this weight loss we admitted 20 nondepressed obese women to a metabolic unit where they were r and omly assigned to 3 wk of a 1.76-MJ/d formula diet and either 60 mg fluoxetine/d or a placebo .  Resting energy expenditure of the control subjects fell below normal after 5.6 + /- 0.6 d of energy restriction , whereas that of the fluoxetine-treated subjects increased by 4.4 + /- 1.8 % ( P < 0.005 ) within 3 d of commencing treatment . This increased resting energy expenditure then reversed and fell below normal after 9.8 + /- 0.9 d of energy restriction . Basal body temperature of the control subjects decreased insignificantly during the period of energy restriction , but that of the fluoxetine-treated subjects increased by 0.28 + /- 0.10 degrees C ( P < 0.05 ) within 3 d of commencing diet and drug treatment . Urinary norepinephrine excretion and the serum triiodothyronine concentration decreased equally in both groups . Despite identical energy intakes and equal nitrogen balance , the fluoxetine-treated subjects lost weight faster than the control subjects during the final week of energy restriction ( P < 0.05 ) . We propose that serotonin reuptake inhibition increases energy expenditure by increasing basal body temperature Forty-five obese subjects with a mean weight of 102.9 kg and a body mass index ( in kg/m2 ) of 37.6 were r and omly assigned to a fluoxetine-diet group ( n = 23 ) or a placebo-diet group ( n = 22 ) for 52 wk . At week 29 , 14 subjects on fluoxetine who completed the study attained their maximum weight loss of 12.4 kg , an amount significantly greater than the maximum weight loss of 4.5 kg for the 16 on placebo who completed the study . The fluoxetine group 's significantly greater mean weight loss continued through week 45 . However , those on fluoxetine  regained a mean of 4.2 kg from their lowest weight ( P less than 0.001 ) whereas the placebo group did not . By the end of the study , each group weighed significantly less than they did at baseline ( fluoxetine : -8.2 kg ; placebo : -4.5 kg ; P less than 0.05 ) although the difference between groups was no longer significant ( P greater than 0.05 ) . Several factors were considered as possible causes for the regain with fluoxetine OBJECTIVE The study aims to provide information about variance components of psychosocial outcomes : within and between-participant variance , within-participant correlation and for cluster r and omised trials , the intra-cluster correlation ( ICC ) and , also , to demonstrate how estimates of these variance components and ICCs can be used to design r and omised trials and cluster r and omised trials . METHOD Data from 15 longitudinal multi-centre psycho-oncology studies were analysed , and variance components including ICCs were estimated . Studies with psychosocial outcomes that had at least one measurement post-baseline including individual r and omised controlled trials , cluster r and omised trials and observational studies were included . RESULTS Variance components and ICCs from 87 outcome measures were estimated . The unadjusted , single timepoint ( first post-baseline ) ICCs ranged from 0 to 0.16 , with a median value of 0.022 and inter-quartile range 0 to 0.0605 . The longitudinal ICCs ranged from 0 to 0.09 with a median value of 0.0007 and inter-quartile range 0 to 0.018 . CONCLUSIONS Although the magnitude of variance components and ICCs used for sample -size calculation can not be known in advance of the study , published estimates can help reduce the uncertainty in sample -size calculations . Psycho-oncology research ers should be conservative in their sample -size calculations and use approaches that improve efficiency in their design and analysis Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more AIMS Nicotine replacement therapy ( NRT ) is an established aid in stopping smoking , while the role of antidepressants remains uncertain . Antidepressants added to NRT might improve abstinence rates . Our aim was to determine the efficacy of nicotine inhaler and fluoxetine vs. nicotine inhaler and placebo in attempts to quit smoking . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING A smoker 's cessation clinic . PARTICIPANTS One hundred volunteers smoking 10 cigarettes/day or more . INTERVENTIONS Subjects were instructed to start taking a daily dose of 10 mg of fluoxetine or placebo 16 days before stopping smoking , then 20 mg 10 days before quitting , continuing for up to at least 3 months . Subjects were instructed to use 6 - 12 units per day of nicotine inhalers after stopping smoking for up to 6 months . MEASUREMENTS Continuous abstinence rates recorded at various time points up to 12 months from the quit date . FINDINGS The sustained abstinence rate for the inhaler-fluoxetine group was 54 % , 40 % , 29 % and 21 % after 1.5 , 3 , 6 and 12 months , respectively , compared to 48 % , 40 % , 32 % and 23 % for the inhaler-placebo group . The differences were not significant at any time point . Abstinence up to 3 months was more likely in older smokers , those with a lower Beck Depression Inventory Score ( BDI ) , lower Fagerström Test of Nicotine Dependence ( FTND ) score and no history of alcoholism . Fluoxetine appeared to increase abstinence rates among high BDI smokers compared to high BDI smokers assigned placebo .  Serum levels of nicotine during treatment in the inhaler-fluoxetine group were lower than in the inhaler-placebo group so that fluoxetine may have reduced inhaler use through a common site of action . CONCLUSIONS We found no evidence that fluoxetine treatment when used as an adjunct to NRT in unselected smokers is effective , but there may be an advantage to using it in depressed smokers OBJECTIVE To compare the effectiveness of two interventions in the treatment of obese patients :  hypocaloric diet and hypocaloric diet plus serotoninergic medication . DESIGN R and omised clinical trial . SETTING Primary Care . Out-patient Endocrinology clinic . PATIENTS The trial included 60 obese adults , assigned at r and om to two groups of 30 each . Both groups were comparable for sex , age , weight and Body Mass Index . Weight controls were performed at 2 , 4 and 6 months . RESULTS There were no significant differences in weight losses at the times studied ( 2 , 4 and 6 months ) between the Control ( Hypocaloric diet ) and Study ( Hypocaloric diet plus medication ) groups . There were significant weight losses in both groups analysed between 2 and 4 months , with a Body Mass Index which went down from 36.2 to 34.12 and from 35.52 to 33.57 ( p < 0.001 ) in the Control and Study groups , respectively . CONCLUSIONS No significant differences were observed in the results obtained for obese patients between a hypocaloric diet supplemented by serotoninergic medication and a hypocaloric diet CONTEXT As of 2005 , the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial 's findings in member journals . OBJECTIVE To assess the proportion of registered trials with results recently published in journals with high impact factors ; to compare the primary outcomes specified in trial registries with those reported in the published articles ; and to determine whether primary outcome reporting bias favored significant outcomes . DATA SOURCES AND STUDY SELECTION MEDLINE via PubMed was search ed for reports of r and omized controlled trials ( RCTs ) in 3 medical areas ( cardiology , rheumatology , and gastroenterology ) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors . DATA EXTRACTION For each included article , we obtained the trial registration information using a st and ardized data extraction form . RESULTS Of the 323 included trials , 147 ( 45.5 % ) were adequately registered ( ie , registered before the end of the trial , with the primary outcome clearly specified ) . Trial registration was lacking for 89 published reports ( 27.6 % ) , 45 trials ( 13.9 % ) were registered after the completion of the study , 39 ( 12 % ) were registered with no or an unclear description of the primary outcome , and 3 ( 0.9 % ) were registered after the completion of the study and had an unclear description of the primary outcome . Among articles with trials adequately registered , 31 % ( 46 of 147 ) showed some evidence of discrepancies between the outcomes registered and the outcomes published . The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6 % ( 19 of 23 ) . CONCLUSION Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent Pharmacologic measures which increase serotonergic activity in the brain decrease food consumption and lead to decreased weight in animals .  Fluoxetine , an inhibitor of serotonin reuptake , decreases food intake in animals and is associated with weight loss in depressed and otherwise healthy obese patients . To determine the most effective daily fixed dose which causes weight loss in nondepressed obese patients , fluoxetine ( 10 , 20 , 40 or 60 mg ) or placebo was administered once daily for 8 weeks to 655 patients consisting primarily of women ( mean age 40 years , mean weight 95 kg ) .  Diet and activity were not controlled . The placebo-treated patients lost 0.6 + /- 2.3 kg . With the 60-mg fluoxetine dose , patients lost an average of 4.0 + /- 3.9 kg ( P less than 0.001 ) , with intermediate responses at the lower doses . Weight loss was proportional to the initial body mass index ( weight/height squared ) . There were no statistically significant differences between any fluoxetine treatment group and placebo for discontinuations from the study . There were statistically significant dose-dependent increases in reports of asthenia , somnolence and sweating . Thus , fluoxetine 60 mg daily appears to be potentially effective for use in weight reduction Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently Obesity is a major health care concern because of its associated medical complications and increased mortality . Despite a myriad of short-term weight loss strategies and the motivation of improving health , patients have difficulty maintaining reduced weight . Pharmacologic agents , such as fluoxetine , a selective serotonin uptake inhibitor , have been investigated as adjunctive therapy to st and ard weight management programs . Extended therapy with fluoxetine has demonstrated clinical ly meaningful benefits on weight loss and obesity-associated medical conditions in double-blind placebo-controlled studies . However , the magnitude of these benefits for individuals vary . Such findings are consistent with the belief that the obesity syndrome has differing etiologies . Accordingly not all patients are likely to benefit from a particular therapy . Studies should identify patient subgroups that are more likely to respond to a specific therapy . In this study of 719 fluoxetine-treated and 722 placebo treated patients in four multicenter , r and omized , double-blind , long-term clinical trials , we investigated possible predictors of a beneficial long-term outcome from fluoxetine therapy . Patients ' age , current smoking activity , and baseline uric acid concentration were predictors of a meaningful long-term treatment effect . Further review of the weight loss patterns of patients achieving long-term success provided the basis for a treatment monitor . Use of the predictors and the treatment monitor are strategies to maximize the benefits of therapy through improved patient selection and monitoring during a therapeutic program Data from two large , fixed-dose trials support the efficacy of a fixed 20 mg/day dose of fluoxetine in the treatment of depression . Data pooled from these two studies suggest a dose relationship for adverse events during fluoxetine therapy . At a fixed 20 mg/day dose , only nausea and insomnia were reported by a significantly greater percentage of patients ( p less than .05 ) than those treated with placebo . However , at 60 mg/day , nausea , anxiety , dizziness , and insomnia were reported by a significantly greater percentage of patients ( p less than .05 ) than those treated with placebo . The potential relationship of response rate [ Hamilton Rating Scale for Depression ( HAM-D ) total decrease greater than or equal to 50 % ] to plasma concentrations of fluoxetine , norfluoxetine , and fluoxetine plus norfluoxetine  was evaluated in one study which excluded early responders ( less than or equal to 3 weeks of therapy ) . No significant relationship was found . Furthermore , adverse events were not related to plasma concentrations Context : No long-term studies have compared central ly acting drugs for treating obesity . Objective : To compare the efficacy and safety of diethylpropion ( DEP ) , fenproporex ( FEN ) , mazindol ( MZD ) , fluoxetine ( FXT ) and sibutramine ( SIB ) in promoting weight loss . Design and Setting : A prospect i ve , r and omized , placebo (PCB)-controlled study conducted at a single academic institution . Patients : A total of 174 obese premenopausal women . Intervention : Participants r and omly received DEP 75 mg ( n=28 ) , FEN 25 mg ( n=29 ) , MZD 2 mg ( n=29 ) , SIB 15 mg ( n=30 ) , FXT 20 mg ( n=29 ) or PCB ( n=29 ) daily over 52 weeks . Diet and physical activity were encouraged . Main Outcome Measures : The primary endpoints were changes in body weight and the proportion of women who achieved at least 5 % weight loss by week 52 in the intent-to-treat population . Other measurements included anthropometry , safety , metabolic and cardiovascular parameters . Results : Weight loss was greater than PCB ( −3.1±4.3 kg ) with DEP ( −10.0±6.4 kg ; P<0.001 ) , SIB ( −9.5±5.9 kg ; P<0.001 ) , FEN ( −7.8±6.9 kg ; P<0.01 ) and MZD ( −7.4±4.9 kg ; P<0.01 ) but not with FXT ( −2.5±4.1 kg ) . Ten ( 33.3 % ) women lost⩾5 % of their initial weight with PCB , compared with 20 ( 71.4 % ; P<0.001 ) with DEP , 20 ( 69 % ; P<0.02 ) with FEN , 21 ( 72.4 % ; P<0.01 ) with MZD , 22 ( 73.3 % ; P<0.001 ) with SIB and 10 ( 35.5 % ) with FXT . Each medically treated group experienced more adverse events compared with PCB ( P<0.001 ) . Compared with PCB , constipation was more prevalent with DEP , SIB and MZD ( P<0.01 ) ; anxiety was more prevalent with DEP ( P=0.01 ) ; and irritability occurred more frequently with DEP and FEN ( P=0.02 ) . Significant improvements in the depression and anxiety scores , binge-eating episodes and quality of life correlated with weight loss . CONCLUSION : The central ly acting drugs DEP , FEN , MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women , with a satisfactory benefit – risk profile Smoking cessation attempts are often complicated by dysphoria/depression , weight gain , craving , and other nicotine withdrawal symptoms . Fluoxetine 's antidepressant and anorectant properties , along with its capacity to attenuate compulsive behavior , suggest that this medication might facilitate smoking cessation treatment . We examined the effect of fluoxetine on smoking cessation in the context of a program that included group cognitive-behavioral therapy ( six weeks ) and transdermal nicotine patch(ten weeks ) . In a double-blind r and omized trial of fluoxetine for smoking cessation , 150 daily smokers were assigned to placebo ( n=48 ) , 20 mg ( n=51 ) , or 40 mg fluoxetine ( n=51 ) . Fluoxetine did not significantly improve smoking cessation rates , either for those with or without major depressive disorder(MDD)histories or elevated current depression . Our results suggest that fluoxetine may moderate withdrawal symptoms , even if that was not manifested in improved smoking cessation rates . Our results , however , clearly favor the use of fluoxetine if weight gain is a major clinical obstacle to smoking cessation Because current weight-reduction treatments have considerable recidivism , a therapy that could help patients maintain weight loss would be of benefit . A six-center , r and omized , double-blind trial compared the effects of the specific serotonin uptake inhibitor , fluoxetine hydrochloride , and placebo on maintenance of weight loss .  Obese out patients who had lost > or = 3.6 kg after 8 weeks of single-blind fluoxetine 60 mg/day in the qualification phase ( N=317 [ 70.4 % of patients entered ] ; mean + /- st and ard deviation [ SD ] weight loss , 6.8 + /- 2.8 kg ) were r and omly assigned to fluoxetine 20 mg/day ( N=104 ) , fluoxetine 60 mg/day ( N=106 ) , or placebo ( N=107 ) for 40 weeks ( maintenance phase ) . Patients received minimal nutrition/dietary counseling . Qualification phase clinic visits were biweekly ; maintenance phase visits were monthly for 4 months , then bimonthly for 6 months . Patients treated with fluoxetine 60 mg/day continued to lose weight for 8 additional weeks ( 16 weeks total ; maximum mean + /- SD weight loss , 7.2 + /- 4.6 kg ) ; those treated with fluoxetine 20 mg/day or placebo began to regain weight . Mean weights remained below baseline values at week 48 ( all groups ) ; treatment differences were not statistically significant . Study completion rates were comparable ( fluoxetine 20 mg/day , 67.3 % ; fluoxetine 60 mg/day , 56.6 % ; placebo , 67.3 % ; p = 0.175 ) . Among commonly reported adverse events ( > 10 % incidence ) , only asthenia was reported statistically significantly ( p < 0.050 ) more frequently with fluoxetine than with placebo . Few patients discontinued for any single adverse event . Fluoxetine 60 mg/day was effective for a longer period than fluoxetine 20 mg/day or placebo in maintaining weight loss . Overall , fluoxetine was safe and well tolerated BACKGROUND There has been a paucity of well- design ed studies comparing selective serotonin reuptake inhibitor ( SSRI ) medications in the treatment of depression in the elderly . This multicenter study was design ed to examine the efficacy and safety of sertraline and fluoxetine in depressed elderly out patients . A secondary objective was to examine the effects of SSRI treatment on quality of life and cognitive function . METHOD Two hundred thirty-six out patients 60 years of age and older who met DSM-III-R criteria for major depressive disorder received 1 week of single-blind placebo before being r and omly assigned to 12 weeks of double-blind , parallel-group treatment with flexible daily doses of either sertraline ( range , 50 - 100 mg ) or fluoxetine ( range , 20 - 40 mg ) . Primary efficacy measures consisted of the 24-item Hamilton Rating Scale for Depression and Clinical Global Impressions scale ratings . Secondary outcome assessment s included clinician- and patient-rated measures of depression symptoms and factors , cognitive functioning , and quality of life , as well as plasma drug concentrations , which were correlated with clinical response . RESULTS Both drugs produced a similarly positive response on the primary efficacy measures , with 12-week responder rates of 73 % for sertraline and 71 % for fluoxetine . Sertraline-treated patients showed statistically greater cognitive improvement on several measures . Both drugs were safe and well tolerated . CONCLUSION Data indicate that both drugs are effective antidepressants for the treatment of depressed elderly out patients . Differences in cognitive performance effects deserve further investigation In this paper we investigated the effect of fluoxetine ( 60 mg/d ) on serum lipids , glucose and insulin concentrations and blood pressure by means of a r and omized , double-blind placebo controlled trial . Thirty-eight overweight ( BMI : 26 - 30 kg/m2 ) , nondiabetic , nonhypertensive men with an abdominal fat distribution ( waist/hip ratio : > 0.97 ) received dietary advice and placebo or fluoxetine  for 12 weeks . The changes in serum parameters and blood pressure in the fluoxetine treated group were not different from the placebo treated group , despite a significantly larger weight loss in the fluoxetine group . In both groups serum total-cholesterol concentrations , serum LDL-cholesterol concentrations and the HDL/LDL ratio were significantly improved after treatment . Reductions in fasting glucose concentration and systolic blood pressure were only significant in the placebo group . A reduction of serum triglycerides and an increase of HDL-cholesterol were found in the fluoxetine treated group . In the total study population the changes in serum lipids seemed to be more strongly related to the change in total body fat or subcutaneous abdominal fat ( assessed by MRI ) compared to the change in visceral fat . The improvement of most of the serum lipids was related to the change in total body fat independent of the mechanism for attaining this fat loss . Our results indicate that fluoxetine treatment has no specific effect beyond that expected for weight loss on serum lipid , glucose and insulin concentrations , and blood pressure in overweight men OBJECTIVE Fluoxetine has been associated with weight loss during acute treatment , but no controlled studies of weight change during long-term treatment with fluoxetine or other selective serotonin reuptake inhibitors have been reported . Weights were assessed for patients whose depressive symptoms had disappeared with acute fluoxetine treatment . Patients were then r and omly assigned to continuation treatment with fluoxetine or placebo . METHOD Patients whose illness had remitted after 12 weeks of treatment with fluoxetine , 20 mg/day , were r and omly assigned to receive up to 38 weeks of treatment with fluoxetine or placebo .  Weight was assessed at each visit . Change in weight was analyzed during the initial 12 weeks of acute treatment and after 14 , 26 , and 38 weeks . Relationships between weight change and body mass index and between weight change and appetite change were assessed . RESULTS During the initial 4 weeks of therapy , a mean absolute weight decrease of 0.4 kg was observed for all patients . Among patients who completed 50 weeks of therapy , the mean absolute weight increase during continuation treatment was similar for both the placebo- and fluoxetine-treated groups . Weight increase was not related to initial body mass index but was related to both poor appetite at study entry and to improvement in appetite after recovery . No patients discontinued therapy because of weight gain . CONCLUSIONS Acute therapy with fluoxetine is associated with modest weight loss . After remission of depressive symptoms , weight gain for patients taking fluoxetine for longer periods is not different from that for patients taking placebo and is most likely related to recovery from depression Obesity is one of the most important health problems , which many people suffer from it . As a chronic disease , it is a precipitating factor for many medical conditions like hypertension , diabetes mellitus , hyperlipidemia , coronary artery disease , sleep apnea syndrome and some malignancies ( breast , uterus , prostate and colon carcinoma ) . With attention to this fact that obesity is an independent risk factor associated with significant increase in morbidity and mortality , treatment of overweight individuals is very important . One of the medications for short-term weight loss is fluoxetin . In this clinical trial study , fluoxetin effect on weight loss induction during 8 weeks was investigated . 201 cases with BMI between 25–42 were selected r and omly ( 113 female and 88 male ) and all received fluoxetine ( 40 mg daily ) for 8 weeks . Measurement was carried out after the 4th and 8th week of administration and 4 weeks after end of treatment . Management of 9 cases ( 4 due to weight gain and 5 due to headache ) were discontinued after 4 weeks of treatment . Data assessment s were performed using t-test and SPSS program . Mean body weight at first visit was 89.32±13.30 kg . At the 4th , 8th week of treatment and 4 weeks after study , the mean body weight of cases reached 86.09±13.27 ( p=0.00 ) , 82.69±11.31 ( p=0.00 ) and 81.97±13.26 ( p=0.00 ) respectively . Mean BMI at first visit was 34.90±5.20kg/m2 . At 4th , 8th weeks of treatment it was 33.72±5.20kg/m2 and 32.40±5.18kg/m2 respectively . Mean weight loss at 4th and 8th weeks of treatment was 3.24 kg and 6.67 kg respectively without any weight gain at the end of the 4th week after discontinuation of the drug . Fluoxetine is an effective , well-tolerated and relatively safe drug for short-term treatment of obesity One hundred and eight patients with major depression were treated with fluoxetine 20 mg/day for 3 weeks . Patients who failed to respond to this open-label treatment were r and omly assigned either to receive fluoxetine 60 mg/day for 5 weeks or to continue treatment with fluoxetine 20 mg/day for an additional 5 weeks . Both treatment groups demonstrated a statistically significant reduction in depressive symptoms , indicating that continued treatment with low-dose fluoxetine may be as effective as an increase in dose in achieving a favorable clinical outcome Eleven healthy male subjects of normal body weight received either 60 mg of the 5-HT re-uptake inhibitor fluoxetine ( FXT ) or matching placebo daily for two weeks , with a minimum one month wash-out period between treatments . Subjects attended on days 1 , 8 and 15 from 08.50 h to 15.15 h in each treatment period when food and fluid intake , body weight , pulse and blood pressure , pupil diameter and plasma levels of FXT and NorFXT  were measured and visual analogue scales ( VAS ) for subjective ratings of hunger , satiety , thirst , mood , arousal , nausea and gastric discomfort were completed . The trial was of a double-blind r and omised crossover design , each subject acting as his own control . FXT reduced food intake by 15.7 per cent on day 1 ; by 12.6 per cent on day 8 but not on day 15 . Hunger ratings were lowered by FXT on days 8 and 15 but not on day 1 . Subjects were less thirsty when taking FXT but there was no concomitant reduction in fluid intake .  FXT produced some mydriasis and slowed heart rate . In two weeks treatment with FXT there was a statistically significant weight loss of 1.07 kg compared to a mean weight gain of 0.15 kg on placebo . The incidence of reported side effects was low , drowsiness and stomach discomfort were reported by some subjects on days 8 and 15 A key component of the Cochrane Collaboration 's risk of bias tool for critically evaluating r and omised trials is the consideration of whether baseline characteristics of the treatment groups being compared are systematic ally different . Considered under the domain of ' selection bias ' , this is currently evaluated by looking at the methods of r and omisation and specifically at the generation of the r and omised allocation sequence and the concealment of this sequence during the process of r and omisation . Assessment of the actual similarity of baseline variables across groups in demographic and clinical characteristics is seldom performed . Even when performed , the link with selection bias is sometimes not considered . Methods of r and omisation and allocation concealment are often poorly reported in published trials , yet baseline data tables are presented in a large majority of trial reports . In this article , we propose that assessment of trial baseline data should form a key and prominent part of selection bias judgements when using the risk of bias tool . We outline the possible benefits from using this approach , including reduced uncertainty in systematic review conclusions , reduced risk of chance findings being ascribed to treatment effects and better use of available evidence by a more considered approach to evaluating studies using imperfect r and omisation and allocation methods Frequent mood and sleep disorders and increased appetite leading to obesity are observed in postmenopausal women . Due to the limitations of hormone replacement therapy the research ers look for other treatment regimes . The aim of the study was to evaluate the efficacy of fluoxetine and melatonin in the treatment of these disorders . The study included 64 overweight postmenopausal women , aged 54 - 65 years , with increased appetite . They were r and omly assigned in 2 groups . In group I ( n = 30 ) fluoxetine ( 20 mg in the morning ) and placebo ( in the evening ) were administered for 24 weeks . Group II ( n = 34 ) received fluoxetine ( 20 mg in the morning ) and melatonin ( 5 mg in the evening ) in the same period of time . Hamilton anxiety rating scale ( HARS ) , Beck depression scale ( BDI ) , the insomnia severity index ( ISI ) and body mass index ( BMI ) were used to assess the health status and the treatment efficacy . After 24 weeks , comparable and statistically significant reduction in the level of anxiety and depression was obtained in both groups . In group I , the ISI decreased from 14.9 ± 2.5 points to 10.9 ± 1.9 points ( P < 0.05 ) and in group II from 15.8 ± 2.4 points to 7.7 ± 1.5 points ( P < 0.001 ) . In group I no reduction in BMI was achieved whereas in group II this index decreased from 30.9 ± 3.1 to 26.3 ± 3.2 ( P < 0.05 ) . We conclude that combined administration of fluoxetine and melatonin was useful option to treat mood , sleep and appetite disorders in postmenopausal women BACKGROUND The effect of extended anti-depressant treatment on weight has been poorly investigated . Also unknown is whether different compounds have differential effects . The aim of the present study was to assess changes in weight in obsessive-compulsive disorder ( OCD ) patients treated for 2.5 years with  clomipramine or selective serotonin reuptake inhibitors . METHOD 138 DSM-IV OCD patients who responded to 6-month acute treatment at the Mood and Anxiety Disorders Unit , Department of Neuroscience , University of Turin , Italy , were followed-up for 2 years while receiving open-label clomipramine , citalopram , fluoxetine , fluvoxamine , paroxetine , or sertraline .  Patients were consecutively recruited and followed from May 1998 to March 2003 . The mean percentage change in weight was compared for each group , as was the proportion of patients who had a > or = 7 % weight increase from baseline . RESULTS At the end of the 2.5-year study period , patients had gained a mean of 2.5 % of their body weight with respect to baseline ( 1.58 kg ) ; 14.5 % of the total sample experienced a significant ( > or = 7 % ) weight increase . Within each but the fluoxetine treatment group , paired t tests showed a significant increase in weight from baseline to final visit . Analysis of variance showed a significant difference between treatment groups ( p = .009 ) , with clomipramine being associated with the highest weight increase and fluoxetine and sertraline with the lowest . A higher proportion of clomipramine-treated patients ( 34.8 % ) gained > or = 7 % in weight as compared with sertraline and fluoxetine , which accounted for the lowest percentage of patients with a significant weight gain ( 4.5 % and 8.7 % , respectively ) , although this difference was not statistically significant . CONCLUSION Risk of weight gain during extended serotonin reuptake inhibitor treatment for OCD differs depending on which compound is used . The differences among antiobsessive drugs may affect compliance with medication and health risks OBJECTIVE To report second-year results from the 2-year maintenance phase of a long-term study to evaluate the efficacy and safety of venlafaxine extended release ( ER ) in preventing recurrence of depression . METHOD Out patients with recurrent unipolar depression ( DSM-IV criteria ; N = 1096 ) were r and omly assigned in a 3:1 ratio to 10 weeks of treatment with venlafaxine ER or fluoxetine . Responders ( 17-item Hamilton Rating Scale for Depression [ HAM-D(17 ) ] total score < or= 12 and > or= 50 % decrease from baseline ) entered a 6-month , double-blind continuation phase on the same medication . Continuation-phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month phases . At the start of each maintenance phase , venlafaxine ER responders were r and omly assigned to receive double-blind treatment with venlafaxine ER or placebo , and fluoxetine responders were continued for each period . The second 12-month maintenance phase compared the time to recurrence of depression with venlafaxine ER ( 75 to 300 mg/day ) versus placebo as the primary efficacy measure . The primary definition of recurrence was a HAM-D(17 ) total score > 12 and < 50 % reduction from baseline ( acute phase ) at 2 consecutive visits or at the last valid visit prior to discontinuation . The time to recurrence was evaluated using Kaplan-Meier methods and compared between the venlafaxine ER and placebo groups using log-rank tests . Secondary outcome measures included rates of response and remission ( defined as HAM-D(17 ) < /= 7 ) . The study was conducted from December 2000 through July 2005 . RESULTS The cumulative probabilities of recurrence through 12 months in the venlafaxine ER ( N = 43 ) and placebo ( N = 40 ) groups were 8.0 % ( 95 % CI = 0.0 to 16.8 ) and 44.8 % ( 95 % CI = 27.6 to 62.0 ) , respectively ( p < .001 ) . At month 12 , using last-observation-carried-forward analysis , the rate of response or remission was significantly higher in the venlafaxine ER group ( 93 % ) than in the placebo group ( 63 % ; p = .002 ) . Overall discontinuation rates were 28 % and 63 % in the venlafaxine ER and placebo groups , respectively . Adverse events were the primary reason for discontinuation for 1 patient ( 2 % ) in the venlafax-ine ER group and 4 ( 10 % ) in the placebo group . An analysis of the combined maintenance phases , which compared the risk of recurrence over 24 months for patients assigned to venlafaxine ER ( N = 129 ) or placebo ( N = 129 ) for the first maintenance phase , showed a significantly greater cumulative probability of recurrence through 24 months for the placebo group ( 47.3 % [ 95 % CI = 36.4 to 58.2 ] ) than for the venlafaxine ER group ( 28.5 % [ 95 % CI = 18.3 to 38.7 ] ; p = .005 ) . CONCLUSION In this study , an additional 12 months of maintenance therapy with venlafaxine ER was effective in preventing recurrence of depression in patients who had been responders to venlafaxine ER  after acute ( 10 weeks ) , continuation ( 6 months ) , and initial maintenance ( 12 months ) therapy . TRIAL REGISTRATION Clinical Trials.gov identifier NCT00046020 ( http://www . clinical trials.gov ) Twelve nondepressed healthy female obese subjects ( BMI > 30 kg/m2 ) took part in a study which conformed to a double-blind r and omized crossover design . Each subject acted as her own control across 2 weeks of treatment with either 60 mg of the 5-HT reuptake inhibitor fluoxetine or matching placebo . On days 7 and 14 of both treatment phases subjects were provided with fixed energy lunch meals high in either CHO or fat . The effect of these meals on satiety during the fluoxetine and placebo phases was assessed by a battery of procedures . Subjects felt less hungry after consuming the high CHO meal than after consuming the high-fat meal . They also felt less hungry when taking fluoxetine than when taking the placebo . Analysis of energy intake from the test meal revealed a main effect of prior lunch meal type ( high CHO or high fat ) and a main effect of drug treatment . Subjects consumed an average of 574 kcal following the high CHO meal compared to 689 kcal following the high-fat meal . Subjects also consumed an average of 532 kcal when taking fluoxetine compared to 730 kcal when taking the placebo . Fluoxetine did not exert any significant effects on macronutrient selection . Mean daily energy intake , calculated from food diary records , was 1881 kcal when subjects were taking the placebo compared to 1460 kcal when taking fluoxetine ( a reduction of 22.4 % ) . Fluoxetine treatment produced a significant weight loss of 1.97 kg over the two weeks of treatment compared to a weight loss of only 0.04 kg on placebo This study assessed the effect of fluoxetine 20 mg/day on weight loss in older patients treated for major depression in a multicenter , double-blind placebo-controlled , 6-week clinical trial . Thirty U.S. outpatient clinics affiliated with psychiatric programs participated in the study that involved 671 medically stable out patients at least 60 years old who had normal cognition and met DSM-III-R criteria for major depression .  Weight was recorded at weekly visits . As a measure of adiposity , patients were categorized into two groups , high and low/normal body mass index ( BMI ) groups . Analyses were done for each group . The high BMI group , but not the low/normal BMI group , had a statistically greater proportion of fluoxetine-treated patients who lost at least 5 % of their baseline weight . Overall mean weight change for the fluoxetine-treated patients was about 1 % compared with essentially no change for placebo-treated patients . Only one patients , who was treated with fluoxetine and in the low/normal BMI group , discontinued from the study because of weight loss . Although 5 % weight loss occurred in more fluoxetine-treated than placebo-treated patients , most of the patients who lost weight had higher adiposity at baseline . There was not a statistically significant difference in the proportion of fluoxetine-treated and placebo-treated patients in the low/normal group who had at least 5 % weight loss . Medically relevant weight loss in older patients treated with fluoxetine was uncommon Studies focusing on the prevalence of obesity in Major Depressive Disorder ( MDD ) , or the impact of excess body fat on the treatment of MDD are lacking . The aim of the present work is to systematic ally study obesity in MDD out patients . A total of 369 MDD out patients enrolled in an 8-wk trial of 20 mg fluoxetine  had height and weight measured at baseline . We then examined : ( 1 ) the prevalence of being overweight or obese , ( 2 ) the relationship between obesity and a number of demographic and clinical variables , and , ( 3 ) the relationship between relative body weight and obesity with clinical response . We found that more than 50 % of patients were overweight [ body mass index ( BMI ) > or = 2 5 kg/m2 ] , while 20 % were obese ( BMI > or = 30 kg/m2 ) . Obese patients presented with worse somatic well-being scores than non-obese MDD patients , but they did not differ with respect to depression severity , anxiety , somatic complaints , hopelessness or hostility . Greater relative body weight , but not obesity , predicted non-response . In conclusion , greater relative body weight was found to place MDD out patients at risk for fluoxetine resistance Current evidence demonstrates that pharmacologic agents , alone or in combination produce short-term weight-loss and may remain effective for extended periods of time in obese patients . We have evaluated the weight loss of a selective inhibitor of serotonin uptake , fluoxetine , alone as compared with combined therapeutic trial with another serotoninergic drug , dexfenfluramine .  Thirty-three patients were r and omly assigned in a double-blind r and omized clinical trial divided to two groups : Group I [ Fluoxetine 40 mg and placebo ( n = 13 ) ] and Group II [ Fluoxetine 40 mg plus dexfenfluramine 15 mg at night ( n = 20 ) ] . Both groups had a significant weight loss at the end of 8 months ( Group I , mean + /- SEM 6.2 + /- 2.8 kg and Group II 13.4 + /- 6.3 kg , p < 0.05 ) . Group II patients had a significantly greater weight loss as compared with Group I both in terms of mean weight loss in kg and BMI in kg/m2 . However significance between Group I and II related to BMI mean values and weight mean values were only achieved after , respectively , 4 and 6 months of treatment . At laboratory level there was an elevation of HDL-cholesterol and lowering of serum lipids values ( cholesterol and triglycerides ) in both groups . Side effects were relatively minor and no altered clinical vital signs or abnormal laboratory values were observed . We concluded that the combination of fluoxetine ( daytime ) and dexfenfluramine ( at night ) may be more effective than fluoxetine alone in weight reduction although the small size of this study does not permit broad generalization Discriminant function analysis of data from a double-blind comparative trial of lofepramine ( a noradrenaline-specific reuptake inhibitor ) and fluoxetine ( a serotonin-specific reuptake inhibitor ) , involving 183 patients was used to identify predictors of response . Psychic anxiety significantly predicted a positive response to antidepressant medication , whereas psychomotor retardation , observed sadness , subjective lassitude and somatic complaints were significant predictors of nonresponse . Age , gender , endogenicity , duration of illness and number of previous episodes were not predictive of response . Significant differences were found between predictors of response to fluoxetine and lofepramine ( P < 0.001 all groups ) . Predictors of response to lofepramine were similar to overall predictors , i.e. , psychic anxiety predicted responders whilst observed sadness , psychomotor retardation , lassitude , inability to feel and somatic complaints predicted nonresponders . In contrast , baseline weight loss predicted response to fluoxetine , whereas anxiety , reduced insight and a tendency to blame others significantly predicted nonresponse . Such findings have practical implication s for the management of depressive illness The authors evaluated the efficacy of fluoxetine hydrochloride ( Prozac ; Eli Lilly and Company , Indianapolis , IN ) as an adjunct to behavioral treatment for smoking cessation . Sixteen sites r and omized 989 smokers to 3 dose conditions : 10 weeks of placebo , 30 mg , or 60 mg fluoxetine per day . Smokers received 9 sessions of individualized cognitive-behavioral therapy , and biologically verified 7-day self-reported abstinence follow-ups were conducted at 1 , 3 , and 6 months posttreatment . Analyses assuming missing data counted as smoking observed no treatment difference in outcomes . Pattern-mixture analysis that estimates treatment effects in the presence of missing data observed enhanced quit rates associated with both the 60-mg and 30-mg doses . Results support a modest , short-term effect of fluoxetine  on smoking cessation and consideration of alternative models for h and ling missing data Rationale Fluoxetine improves affect in clinical syndromes such as depression and premenstrual dysphoric disorder . Little is known about fluoxetine ’s influence on mood changes after quitting smoking , which often resemble sub- clinical depression . Objectives The present study , a re- analysis of previously published data ( Niaura et al. 2002 ) , examined fluoxetine ’s effect on changes in negative and positive affect following quitting smoking . Methods Adult smokers ( n=175 ) without clinical ly significant depression were r and omized on a double-blind basis to receive fluoxetine hydrochloride ( 30 or 60 mg daily ) or placebo for 10 weeks in combination with cognitive-behavioral therapy ( CBT ) for smoking cessation . We postulated that fluoxetine would beneficially influence post-cessation changes in positive and negative affect . Results Mood change across treatment was analyzed using mixed linear modeling controlling for initial level of nicotine dependence , plasma fluoxetine metabolites , and change in cotinine ( a nicotine metabolite ) at each visit . Relative to placebo , those on 60 mg fluoxetine experienced an elevation in positive affect that increased across time [ t(526)=2.50 , P=0.01 ] , and a reduction in negative affect that returned to baseline across time [ t(524)=2.26 , P=0.02 ] . There were no differences between 30 mg and placebo on changes in positive or negative affect . Conclusions Results indicate that 60 mg of fluoxetine improves both positive and negative mood states after quitting smoking and that diminished positive affect may be an overlooked affective response to smoking cessation The effect of fluoxetine on body weight and spontaneous food choice was studied in twenty-three healthy , non-depressed , obese females on an outpatient basis . After a one week placebo run-in period , subjects were r and omized to receive either fluoxetine ( FXT ) 60 mg daily ( n = 11 ) or placebo ( P ) ( n = 12 ) for 6 weeks in a double blind study design .  BMI ( 35.2 + /- 0.8 vs 36.4 + /- 1.3 kg/m2 , mean + /- s.e.m . ) and age ( 38.1 + /- 239 vs 37.3 + /- 2.7 years ) were not different in either group . No specific diet was prescribed . On four separate days per 14 days food records were collected . Data were analysed with the use of food composition tables . Statistical analysis was performed using Student 's t test for independent sample s for data on body weight and calorie intake . Macro-nutrient composition of the diet was analysed using multivariate analysis of variance and post hoc Student 's t test for independent sample s. All subjects lost weight during fluoxetine treatment . Mean ( + /- s.e.m . ) weight loss in the fluoxetine treated group was 3.6 + /- 0.5 kg , compared to a mean weight gain of 0.3 + /- 0.5 kg in the placebo treated group ( P less than 0.001 ) . In all patients food intake was reduced during fluoxetine treatment and this reduction could fully account for the observed weight loss . The mean total caloric intake per day was significantly lower during fluoxetine treatment compared with placebo ( FXT 1123 + /- 118 kcal vs P 1845 + /- 87 kcal , P less than 0.001 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Fluoxetine 's effect ( 30 mg , 60 mg , and placebo ) on postcessation weight gain was studied among participants from a r and omized , double-blind 10-week smoking cessation trial who met strict criteria for abstinence and drug levels . It was hypothesized that ( a ) fluoxetine would dose-dependently suppress postcessation weight gain and ( b ) drug discontinuation would produce dose-dependent weight rebound . During the on-drug phase , placebo participants gained weight linearly ( M = 2.61 kg ) . exceeding both fluoxetine groups ( 30-mg group M = 1.33 kg , 60-mg group M = 1.25 kg ) . Weight suppression was initially greater for 60 mg than 30 mg , but both were followed by weight gain . Six months off drug produced greater dose-dependent weight rebound for 60 mg than 30 mg or placebo . Considering both on- and off-drug phases , weight gain for 60 mg of fluoxetine ( M = 6.5 kg ) was comparable with that for placebo ( M = 4.7 kg ) but greater than that for 30 mg ( M = 3.6 kg ) . Fluoxetine appears to forestall postcessation weight gain , allowing time for the weight-conscious smoker to focus on quitting smoking rather than on preventing weight gain OBJECTIVE The purpose of this study was to determine prospect ively the optimal length of therapy in a long-term , placebo-controlled continuation study of patients who responded to acute fluoxetine treatment for major depression ( defined by DSM-III-R ) . METHOD The study was conducted at five outpatient psychiatric clinics in the United States . Patients who met criteria for remission after 12 or 14 weeks of open-label acute fluoxetine therapy , 20 mg/day ( N=395 of 839 patients ) , were r and omly assigned to one of four arms of a double-blind treatment study ( 50 weeks of placebo , 14 weeks of fluoxetine and then 36 weeks of placebo , 38 weeks of fluoxetine and then 12 weeks of placebo , or 50 weeks of fluoxetine ) . Relapse rate was the primary outcome measure . Both Kaplan-Meier estimates and observed relapse rates were assessed in three fixed 12-week intervals after double-blind transfers from fluoxetine to placebo at the start of the double-blind period and after 14 and 38 weeks of continued fluoxetine treatment . RESULTS Relapse rates ( Kaplan-Meier estimates ) were lower among the patients who continued to take fluoxetine compared with those transferred to placebo in both the first interval , after 24 total weeks of treatment ( fluoxetine , 26.4 % ; placebo , 48.6 % ) , and the second interval , after 38 total weeks of treatment ( fluoxetine , 9.0 % ; placebo , 23.2 % ) . In the third interval , after 62 total weeks of treatment , rates were not significantly different between the groups ( fluoxetine , 10.7 % ; placebo , 16.2 % ) . CONCLUSIONS Patients treated with fluoxetine for 12 weeks whose depressive symptoms remit should continue treatment with fluoxetine for at least an additional 26 weeks to minimize the risk of relapse A total of 27 subjects began active treatment in this double-blind study comparing the efficacy and safety of trazodone and fluoxetine in geriatric depressed patients , but only 13 completed 6 weeks on study medication . Both agents were effective according to weekly and endpoint analyses , and there was no evidence of significant effects on blood pressure , pulse , or weight . Separate analysis of patients who had received an adequate trial of medication indicated a trend toward relatively more fluoxetine-treated patients meeting clinical criteria for resolved depression . ( J Geriatr Psychiatry Neurol 1989;2:208 - 214 . Our study aims at assessing the efficacy and safety of fluoxetine as compared with placebo in the treatment of obesity using a double-blind crossover design . We studied 42 obese women ( body mass index 35.9 + /- 5.3 kg/m2 ) . The obese patients were r and omized to start treatment with fluoxetine ( group A ) or placebo ( group B ) for 3 months ( period 1 ) . After a 1-month washout period , treatment was crossed for the following 3 months ( period 2 ) . There was no significant difference in weight loss when the patients were treated with fluoxetine ( group A period 1 and group B period 2 ) as compared with patients treated with placebo ( group B period 1 and group A period 2 ) . There were no significant differences in monthly weight reduction during both treatments . In conclusion , we demonstrated that serotoninergic drugs such as fluoxetine need further investigation before being used indiscriminately in obese subjects
target: Low-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo .
  However , low-certainty evidence suggests an increase in the risk for dizziness , drowsiness , fatigue , insomnia and nausea following fluoxetine treatment
background: BACKGROUND Fluoxetine is a serotonin reuptake inhibitor indicated for major depression .
  It is also thought to affect weight control : this seems to happen through appetite changes result ing in decreased food intake and normalisation of unusual eating behaviours .
  However , the benefit-risk ratio of this off-label medication is unclear .
  OBJECTIVES To assess the effects of fluoxetine for overweight or obese adults .