title: Fluoxetine in depressed patients: a comparison with imipramine. Comparison of pramipexole, fluoxetine, and placebo in patients with major depression. A comparative clinical trial of fluoxetine, mianserin and placebo in depressed outpatients Efficacy and safety of tianeptine in the treatment of depressive disorders in comparison with fluoxetine. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder. Compliance in depressed patients treated with fluoxetine or amitriptyline Comparison of equivalence between the St. John's wort extract LoHyp-57 and fluoxetine. A comparative trial of fluoxetine versus trazodone in outpatients with major depression. A comparison of fluoxetine imipramine and placebo in patients with bipolar depressive disorder. Fluoxetine versus phenelzine in atypical depression A comparison of fluoxetine and amitriptyline in the treatment of major depression. Fluoxetine versus amitriptyline in the treatment of major depression with associated anxiety (anxious depression): a double-blind comparison. Double-blind comparison of bupropion and fluoxetine in depressed outpatients. Fluoxetine versus trazodone in the treatment of outpatients with major depression. A double-blind comparison of venlafaxine and fluoxetine for treatment of major depression in outpatients A double‐blind, comparative, multicentre study comparing paroxetine with fluoxetine in depressed patients A comparison of fluoxetine, imipramine, and placebo in patients with major depressive disorder. Effectiveness of fluoxetine and doxepin in treatment of melancholia in depressed patients. A double‐blind comparison of the efficacy and safety of milnacipran and fluoxetine in depressed inpatients Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression Fluoxetine versus amineptine in the treatment of outpatients with major depressive disorders. Is Baseline Agitation a Relative Contraindication for a Selective Serotonin Reuptake Inhibitor: A Comparative Trial of Fluoxetine Versus Imipramine A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression. Moclobemide versus fluoxetine for a major depressive episode Is anxious-agitated major depression responsive to fluoxetine? A double-blind comparison with amitriptyline. Fluoxetine Versus Trazodone in Depressed Geriatric Patients Moclobemide versus fluoxetine for a major depressive episode A double-blind controlled comparison of fluoxetine and lofepramine in major depressive illness
abstract: The clinical efficacy and safety of fluoxetine and imipramine were compared in a double-blind , 5-week , parallel study in 40 depressed out patients .  Mean scores for most depression scales improved more in patients taking fluoxetine than in those receiving imipramine ( p less than .05 ) . Nine of 16 ( 56 % ) fluoxetine patients who completed the study and 1 of 19 ( 5 % ) imipramine patients were not at all depressed at the end of the study ( p less than .001 ) . Seven fluoxetine patients and 14 imipramine patients reported one or more adverse effects during treatment ; no fluoxetine patient terminated the study early for drug-related reasons . It was concluded that fluoxetine provides effective antidepressant activity with fewer and less troublesome side effects than imipramine Pramipexole , a dopamine D2 receptor agonist , was tested in 174 patients with major depression , with or without melancholia and without psychotic features . Three daily dose levels ( 0.375 mg , 1.0 mg , and 5.0 mg ) were compared to fluoxetine ( Prozac ) at 20 mg and placebo in a r and omized , double-blind , parallel-group study . After a 1 week placebo run-in period , patients were treated for 8 weeks , had a post- study follow-up ( week 9 ) , and were evaluated primarily with the Hamilton Psychiatric Rating Scale for Depression ( HAM-D ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Clinician 's Global Impressions-Severity of Illness scale ( CGI-SI ) .  All patients who received one dose of study medication were included in the observed-case analysis ( no missing data were replaced ) . Results indicated that by endpoint ( week 8) , patients receiving pramipexole at the 1.0 mg per day dose had significant improvement over baseline compared to the placebo group by measure of the HAM-D , MADRS , and CGI-SI . Significant improvement in this dose group was seen at other timepoints as well . The most obvious improvement was seen in the pramipexole 5.0 mg group , although a substantial dropout rate for this group precluded statistical tests vs. placebo late in the study . Patients taking fluoxetine also showed significant improvements at endpoint on the MADRS and earlier in the study on the HAM-D. No new or unusual safety concerns were generated during this study . Pramipexole helped safely alleviate the symptoms of depression at 1.0 mg per day and especially in those patients who could tolerate the escalation to 5 mg per day Fluoxetine , a selective serotonin reuptake inhibitor , was compared with mianserin and placebo in a double‐blind study . In total , 81 depressed patients were included . Patients were rated weekly on the Hamilton Depression Rating Scale ( HDRS ) and the Montgomery & Asberg Depression Rating Scale ( MADRS ) . The duration was 6 weeks , and 52 patients completed the study . Significantly more patients on fluoxetine improved than patients on placebo . For mianserin no significant differences were found with either fluoxetine or placebo . Mean HDRS at the end of the study was also statistically significantly lower for fluoxetine , but not for mianserin , than placebo . Subscores of the MADRS showed improved sleep on mianserin at weeks 2 and 3 . Suicidal feelings were reduced to a greater degree on fluoxetine than on mianserin and placebo at weeks 6 and 7 . Fluoxetine  induced weight loss , while patients on mianserin gained weight . Side effects were present in most patients on the two active drugs ; those on fluoxetine experienced nausea and vomiting , and those on mianserin drowsiness BACKGROUND Depression is treated by a great variety of antidepressant treatments . SSRIs ( such as fluoxetine ) are well known : it is , however , sure that further progress is needed and the search for antidepressants with other mechanisms of action ( such as tianeptine ) or different efficacy is still of interest . METHODS A multinational study compared tianeptine with fluoxetine in 387 patients with Depressive Episode , or Recurrent Depressive Disorder , or Bipolar Affective Disorder ( ICD-10 ) , in a double-blind parallel group design . They were treated for six weeks . RESULTS At inclusion , no significant difference between groups was shown . Final MADRS scores were 15.7 and 15.8 with tianeptine and fluoxetine , respectively ( ITT population ) ( p = 0.944 ) . MADRS responders were 58 % and 56 % with tianeptine and fluoxetine , respectively ( p = 0.710 ) . No statistical difference was observed for the other efficacy parameters . Thirty-six withdrawals occurred in each group , without any difference for the reasons of discontinuation . There was no major difference between groups for the other safety parameters . CONCLUSIONS In this study , both tianeptine and fluoxetine exhibited a good efficacy and safety BACKGROUND Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors . In a 12-week r and omized , multicenter , double-blind trial , the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in patients with moderate to severe depression . METHODS A total of 203 patients were r and omized to fixed doses ( 20 mg/day ) of paroxetine or fluoxetine for the first six weeks of therapy . From week 7 - 12 , dosing could be adjusted biweekly , as required ( paroxetine 20 - 50 mg/day , and fluoxetine 20 - 80 mg/day ) . The mean prescribed doses were paroxetine 25.5 mg/day ( range 20.0 - 40.2 mg/day ) , and fluoxetine 27.5 mg/day ( range 20.0 - 59.5 mg/day ) . Emergence of motor nervousness or restlessness was assessed using the ESRS scale for akathisia . RESULTS Both active treatments demonstrated comparable antidepressant efficacy ( HAM-D , CGI ) . Anxiolytic activity of the two drugs ( COVI , STAI , HAM-D ) was also comparable . However , paroxetine was found to be superior to fluoxetine on two subscore measures at week 1 of therapy ( HAM-D Agitation item , p < 0.05 ; Psychic Anxiety item , p < 0.05 ) , with no differences detected after week 2 . The overall incidence of adverse effects was comparable in the two treatment groups . Constipation , dyspepsia , tremor , sweating and abnormal ejaculation were more common in paroxetine-treated subjects , whereas nausea and nervousness were more frequent in fluoxetine-treated patients . Weight loss was more common in the fluoxetine versus paroxetine group ( 11.88 % versus 2.94 % , respectively ) . ESRS scores for akathisia were low throughout the study and showed little change . LIMITATIONS Differences observed between the two drugs in antianxiety effects were limited to two measures of anxiety among several others . DISCUSSION The data indicate that paroxetine and fluoxetine have comparable antidepressant and anxiolytic efficacy .  Paroxetine appears to produce an earlier improvement in agitation and psychic anxiety symptoms compared with fluoxetine Two dimensions of compliance ( drop-outs and adherence ) were investigated in patients treated with antidepressant drugs .  Efficacy , compliance and its determinants were investigated in 66 patients suffering from major depressive disorder and treated in a double-blind manner with fluoxetine 20 mg/day or amitriptyline 150 mg/day for 9 weeks . Overall effectiveness [ 50 % decrease in the initial Hamilton Rating Scale for Depression ( HAM-D ) ] was similar in both groups ( 62.8 % for fluoxetine , 58.1 % for amitriptyline ) . The dropout rate due to side effects was 35.5 % for amitriptyline and 5.7 % for fluoxetine . A logistic regression analysis revealed that the initial HAM-D score was not predictive for dropping out , but this outcome was instead determined by sex ( increased risk for males ) , age ( increased risk for being younger ) and occurrence of severe side effects . Adherence was estimated using electronic Medication Event Monitoring System and defined as the percentage of days when the correct dose was taken out of the medication container . Of the patients studied 37 % had an adherence of less than 70 % . There was no relationship between adherence and efficacy and adherence was similar in patients on fluoxetine or amitriptyline .  Side effects were not predictive of being adherent or not , but a higher initial HAM-D score predicted a higher adherence to the medication regimen . The demographic variables bad no significant effect . The present study suggests that the link between efficacy , side effects and compliance or adherence is more complex than is generally believed and that early termination and non-adherence seem to be determined by different factors In a r and omised double-blind comparative trial , the antidepressant efficacy of a daily dose of 800 mg of the St. John 's wort extract LoHyp-57 ( dry extract of St. John 's wort , drug extrakt ratio 5 - 7:1 , solvent , ethanol 60 % [ w/w ] ) was shown to be equivalent to that of 20 mg fluoxetine ( CAS 54910 - 89 - 3 ) in elderly patients with mild or moderate depressive episodes according to ICD 10 ( International Statistical Classification of Diseases and Related Health Problems ) . Treatment was given for six weeks . 149 out- patients ( 129 females and 20 males ) were included in the intention-to-treat analysis . 72 of these patients were assigned to the ICD 10 diagnostic criterion F32.0 ( mild depressive episode ) , while 77 patients were suffering from moderate depressive episodes , corresponding to F32.1 . The principal target criterion was the patient 's global score on the HAMILTON Depression Scale ( items 1 - 17 ) . During the six-week course of treatment with LoHyp-57 , the HAMILTON global score fell from 16.60 points at entry to 7.91 points , and in the fluoxetine sample it fell from 17.18 to 8.11 points . In the group of patients with mild depressive episodes , the score showed a mean fall from 14.21 to 6.21 points on LoHyp-57 , and from 15.21 to 7.46 points on fluoxetine . In patients with moderate depressive episodes , the score showed a mean fall from 18.73 to 9.43 points on LoHyp-57 and from 19.10 to 8.75 points on fluoxetine . The efficacy of both medications was found to be equivalent both in mild and moderate depressive episodes . Both treatment groups showed adverse drug reactions ( ADRs ) . Twelve ADRs with a possible relationship to the study medication were reported during treatment with LoHyp-57 . Six patients were prematurely withdrawn from treatment with the study medication for this reason . On fluoxetine 17 ADRs occurred with a possible relationship to the study medication . These led to ab and onment of treatment and therefore premature withdrawal from the study in 8 cases The effectiveness of fluoxetine as an antidepressant was contrasted with trazodone in a 6-week double-blind trial in 40 patients . The total score on the Hamilton Rating Scale for Depression and the global improvement score on the Clinical Global Impressions scale favored trazodone at the end of 3 weeks of treatment . However , that difference was no longer apparent during the remainder of the study . The authors hypothesize that fluoxetine 20 mg/day may be an ineffective dosage of the drug or that fluoxetine has a slower onset of antidepressant action than does trazodone This was a 6-week , double-blind comparison of fluoxetine , imipramine , and placebo in 89 patients with bipolar depression . Using the criteria of greater than or equal to 50 % improvement in the HAMD-total score after at least 3 weeks on study drug , endpoint analysis showed 86 % of the fluoxetine-treated patients improved compared with 57 % of the imipramine-treated and 38 % of the placebo-treated patients . Significantly fewer fluoxetine-treated patients discontinued due to adverse events than did imipramine-treated patients ( 7 % vs. 30 % , respectively ) A study was conducted to compare the relative efficacy of fluoxetine and phenelzine in patients with mood-reactive atypical depression . Forty-two patients with atypical depression by the Columbia criteria were studied in a r and omized , double-blind treatment study . Following a single-blind placebo lead-in , patients received fluoxetine 20 - 60 mg/day or phenelzine 45 - 90 mg/day for 6 weeks . Efficacy was measured by the Hamilton Depression Rating Scale , the Clinical Global Impression ( Severity and Improvement ) scales , and the Patient Global Impression ( Improvement ) scale .  Of 42 patients r and omized , 2 patients never received drugs and 2 phenelzine-treated patients dropped out prior to completion ; the remainder completed the 6 weeks of the study . The rates of treatment response did not differ between groups . With a few exceptions ( e.g. , tremor ) , phenelzine produced more frequent adverse effects than fluoxetine . It was concluded that fluoxetine is as effective as phenelzine in the treatment of atypical depression , but produces fewer adverse effects and is better tolerated Fluoxetine , a new serotonin uptake blocking antidepressant , was compared with amitriptyline in a double-blind study . Patients were diagnosed as having major depression , according to DSM-III criteria , when interviewed with the Diagnostic Interview Schedule . There was significant improvement in patient and observer ratings of depression in both groups , with no difference between groups . Recent memory improved significantly in the fluoxetine group but not in the amitriptyline group . Numbers of patients reporting side-effects were similar but the profiles of side-effects were different , with more patients on amitriptyline reporting anticholinergic and intolerable side-effects Although common in clinical setting s , major depressive disorder with associated anxious symptoms ( ' anxious depression ' ) has not been well studied in antidepressant clinical trials . The aim of this study was to compare the effects of fluoxetine versus amitriptyline in this group of patients . After a single-blind placebo run-in period of 2 weeks , patients were treated on a double-blind basis with fluoxetine or amitriptyline for 8 weeks . Assessment instruments included : 21-item Hamilton Rating Scale for Depression , Hamilton Rating Scale for Anxiety , Clinical Global Impressions , Raskin Depression Scale and Covi Anxiety Scale . A total of 157 patients were r and omized to either fluoxetine or amitriptyline . Fluoxetine was given at a fixed dose of 20 mg/day and amitriptyline was given in a range of 50 - 250 mg/day ( mean of 138.1 mg/day ) . Fluoxetine was comparable to amitriptyline in all efficacy measures except the HAMD sleep factor . Unwanted effects were more frequent and more severe in the amitriptyline-treated patients . Fluoxetine was comparably efficacious to amitriptyline in the treatment of major depression with associated anxiety .  Since fluoxetine was far better tolerated , it is a promising alternative for this frequent and disabling condition BACKGROUND This study was undertaken to compare the efficacy and safety of bupropion and fluoxetine . METHOD Moderately to severely depressed out patients who fulfilled the DSM-III-R criteria for nonpsychotic major depressive disorder and had a score of 20 or more on the Hamilton Rating Scale for Depression ( 21 item ) participated in this two-center study . Following a 1-week placebo phase , patients were r and omly assigned to receive either bupropion or fluoxetine for 6 weeks of double-blind treatment . Weekly efficacy assessment s included Hamilton Rating Scale for Depression , Hamilton Rating Scale for Anxiety , Clinical Global Impressions-Severity , and Clinical Global Impressions-Improvement . Vital signs and adverse experiences were also assessed weekly . RESULTS A total of 61 patients were r and omly assigned to receive bupropion ( 225 - 450 mg/day ) and 62 were r and omly assigned to receive fluoxetine ( 20 - 80 mg/day ) . The mean daily dose at the end of the study was 382 mg/day for the bupropion treatment group and 38 mg/day for the fluoxetine treatment group . There were no statistically significant differences between treatments on any of the efficacy variables . On the basis of a 50 % or greater reduction in the HAM-D scores , 63 % ( N = 37 ) of the bupropion-treated and 58 % ( N = 35 ) of the fluoxetine-treated patients were categorized as responders , and on the basis of CGI scores , 68 % ( N = 40 ) of the bupropion-treated and 58 % ( N = 35 ) of the fluoxetine-treated patients were rated as much or very much improved . HAM-A scores decreased by 59 % for both treatment groups . The incidence of treatment-emergent adverse events was low with no statistically significant differences between treatments . Twenty-six percent ( N = 16 ) of the bupropion-treated and 29 % ( N = 18 ) of the fluoxetine-treated patients prematurely discontinued treatment . CONCLUSION Both bupropion and fluoxetine demonstrated similar efficacy in relieving depression and accompanying symptoms of anxiety , and both exhibited a similar , favorable safety profile Fluoxetine and trazodone were compared in a double-blind , r and omized , parallel , 6-week trial in 43 out patients with major depression after a 1-week single-blind placebo period . Thirty-five patients completed at least 3 weeks of active medication , while 25 patients completed all 6 weeks . Response rates , whether defined by end-of-treatment Hamilton Rating Scale for Depression ( HAM-D ) score less than 10 or by a 50 % reduction in HAM-D scores , were equivalent for the two medications . For fluoxetine , HAM-D scores were significantly lower at Weeks 1 and 2 compared with those of trazodone . Trazodone  improved sleep significantly more than fluoxetine . Fluoxetine was associated more frequently with weight loss ( p = .002 ) and less frequently with dizziness ( p = .04 ) than trazodone 1 . This was a r and omized , double-blind comparison of the efficacy and safety of venlafaxine and fluoxetine in out patients with major depression . 2 . Three hundred fourteen patients were r and omly assigned to either venlafaxine 37.5 mg twice daily or fluoxetine 20 mg once daily for a maximum of 8 weeks . 3 . If the response was inadequate after two weeks of treatment , the dosage of venlafaxine could be increased to 75 mg twice daily . 4 . A clinical response , defined as at least a 50 % decrease from baseline in the total HAM-D score , was attained at week 6 in 72 % of patients on venlafaxine and 60 % of patients on fluoxetine ( p = 0.023 ) . 5 . Among patients who increased their dose at 2 weeks , venlafaxine was significantly ( p < 0.05 ) superior from week 3 onward on the HAM-D. 6 . Venlafaxine 75 mg daily is comparable to fluoxetine , but at 150 mg daily , it may be superior to fluoxetine in out patients with major depression who do not respond early to treatment A r and omized , double‐blind , parallel‐group , 6‐week study was undertaken to compare the efficacy and tolerability of once or twice daily administration of the selective serotonin reuptake inhibitors paroxetine and fluoxetine . After a 1‐week placebo wash‐out , patients suffering from DSM‐III major depression and with a score of 18 or more on the 21‐item Hamilton Rating Scale for Depression ( HRSD ) received either paroxetine or fluoxetine . The patients were assessed for efficacy using the HRSD , Montgomery‐Åsberg Depression Rating Scale and Clinical Global Impression ; for tolerability , adverse events were elicited by the use of a non‐leading question and a side effects checklist . The groups of patients were comparable on entry to the study . One hundred patients were recruited into the study , of whom 78 were evaluable for the efficacy analysis .  Paroxetine and fluoxetine showed comparable efficacy at the end of the 6‐week treatment period , but a statistically significant difference in the number of responders at week 3 in favour of paroxetine was observed . This could suggest an earlier onset of action with paroxetine .  Also , associated anxiety symptoms were significantly reduced on paroxetine compared with fluoxetine at week 3 . Patients on paroxetine reported fewer adverse events than those on fluoxetine . The most commonly reported adverse events were nausea and vomiting in both groups The efficacy and safety of fluoxetine were compared with those of imipramine and of placebo in a 6-week r and omized double-blind parallel study of patients with major depressive illness .  Mean values for all efficacy measurements were improved over baseline with fluoxetine and imipramine treatment ( p less than .001 ) . More fluoxetine patients completed the study than did  imipramine or placebo patients . Predominant adverse experiences reported by imipramine patients were dry mouth and dizziness/lightheadedness . Predominant adverse experiences reported by fluoxetine patients were drowsiness/sedation and excessive sweating . In a subsequent 48-week open-label study , the predominant adverse experience in the fluoxetine group was excessive sweating and in the imipramine group was still dry mouth . In this study , fluoxetine relieved the symptoms of major depressive illness effectively and significantly better than placebo and was better tolerated than imipramine It has been suggested that serotonin reuptake inhibitors ( SSRIs ) may be less effective than tricyclic antidepressants ( TCAs ) in treatment of melancholic depression . We treated 36 depressed ambulatory patients with doxepin or fluoxetine  in a double-blind , r and omized 6-week trial with placebo run-in . Seven patients treated with doxepin and 13 patients treated with fluoxetine met diagnostic criteria for melancholic depression . Average daily dose was 169.4 + /- 41.6 mg for doxepin and 36.8 + /- 18 mg for fluoxetine . We observed a 50 % response rate in both treatment groups , using as outcome criterion reduction of Hamilton Depression Scale Score to less than 10 . Regardless of how strict the definition of response , we found fluoxetine to be as effective as doxepin in our group of melancholic out patients This double-blind , r and omised , multicentre study compared the antidepressant efficacy and safety of two doses of milnacipran ( 100 mg/day and 200 mg/day ) and fluoxetine ( 20 mg/day ) in 289 in patients with endogenous depression . After a placebo washout period of 4–7 days , assessment s were performed weekly during ; the first 4 weeks , and then after 6 , 8 and 12 weeks , using the 17-itein Hamilton Depression Rating Scale ( HDRS ) . the Montgomery - Åsberg Depression Rating Scale ( MADRS ) and the Clinical Global Impression ( CGI ) . HDRS total score was reduced by a mean of 14.8 in the milnacipran 100 mg/day group , 12.9 in the milnacipran 200 mg/day group and 12.1 in the fluoxetine  20 mg/day group . MADRS total score decreased by 17.4 , 15.8 and 14.6 , respectively . No significant difference could be shown between the three treatment groups for either the HDRS or MADRS total scores . However , the time-by-time change showed a trend in favour of milnacipran 100 mg/day , which was found significantly superior to fluoxetine at day 28 for several converging parameters ( MADRS , CGI-3 ) . Overall , efficacy ratings for all parameters were highest for milnacipran 100 mg/day , followed by milnacipran 200 mg/day and fluoxetinc 20 mg/day . Side-effect profiles were not significantly different between groups except for a significantly greater frequency of dose-related increase hi heart rate ≥ 100 bpm in milnacipran recipients and a significantly greater weight loss in fluoxetine recipients In a r and omized , controlled , double-blind trial , 70 patients ( mean age , 49.7 years ) suffering from mild to moderate depression received one tablet of either  St. John ’s Wort ( Hypericum perforatum ) extract ( Calmigen ® ) or fluoxetine hydrochloride ( Prozac ® ) twice a day for 6 weeks . Efficacy was determined according to the 17-item Hamilton Rating Scale for Depression ( HAMD ) , the von Zerssen depression scale ( DS ) , Clinical Global Impression ( CGI ) , and patients ’ overall evaluation . Significant decreases ( P<.001 ) of 50 % in theHypericum group and 58 % in the fluoxetine group in the HAMD score and of 42 % and 52 % on the DS spoke to the efficacy of both medications . TheHypericum extract achieved 83 % of the efficacy of fluoxetine on the HAMD and 78 % on the DS . Assessment s by physicians ( CGI ) and patients indicated considerable improvement with no between-treatment differences . Of the 9 dropouts ( 13 % ) , 2 in theHypericum group and 2 in the fluoxetine group were due to adverse reactions . Safety evaluations demonstrated only minor changes . TheHypericum preparation tested in this study is therapeutically equivalent to fluoxetine and is therefore a rational alternative to synthetic antidepressants Fluoxetine , a selective serotonin reuptake inhibitor , was compared to amineptine , a tricyclic antidepressant agent , in the treatment of 63 out patients with major depressive disorders of mild or moderate severity . Patients were r and omly assigned to 6 weeks of treatment with either fluoxetine or amineptine . Fluoxetine was found to have a more marked therapeutic effect than that of amineptine : better efficacy , fewer side-effects , and quicker and better improvement on the self evaluation scales A common presentation for major depression includes psychomotor agitation . However , this subtype has been the infrequent subject of controlled investigation during depression trials . Yet , the subcategorization of agitated depression has historically been associated with the belief that older , sedating compounds have a superior risk : benefit profile . In the 8-week , double-blind , r and omized , parallel trial , 124 subjects with Research Diagnostic Criteria -compatible agitated depression were r and omized to either imipramine ( IMI ) or fluoxetine ( FLU ) . Both compounds proved to be similarly effective as measured by change in HAM-D17 , HAM-D17 response , and HAM-D17 remission rates . Similar comparability was seen in secondary measures of agitation , anxiety , suicidality , and global impressions . However , of note , a statistically significant difference in early discontinuations because of intolerable adverse events emerged . Whereas 43.5 % of IMI subjects discontinued early , only 9.7 % of FLU subjects ( p < 0.001 ) did . Significantly more central nervous system events characterized the IMI than the FLU subgroup ( IMI , 24.2 % , vs. FLU , 6.5 % ; p = 0.006 ) . In conclusion , among subjects with major depression , subtype agitated , the risk : benefit profile favored FLU over IMI . This was driven by the superior tolerance of FLU . No evidence emerged in support of the clinical hypothesis that a “ sedating ” agent is the treatment of choice for this group . The results are important when striving to maximize compliance with pharmacotherapy in order to minimize recidivism and associated psychological and economic morbidity . ( J Clin Psychopharmacol 1994;14:385–391 BACKGROUND Sertraline and fluoxetine have pharmacokinetic and pharmacologic differences , which may be of clinical relevance . METHOD A r and omized , double-blind , parallel-group study of 6 weeks ' duration comparing the efficacy and safety of sertraline ( 50 - 100 mg/day ) with those of fluoxetine ( 20 - 40 mg/day ) was conducted in 286 psychiatric out patients with DSM-III-R major depression or bipolar disorder ( depressed ) . Primary efficacy measurements consisted of the 17-item Hamilton Rating Scale for Depression ( HAM-D ) and the Clinical Global Impressions ( CGI ) scale . Secondary measurements included the Hamilton Rating Scale for Anxiety ( HAM-A ) , the Raskin Depression Scale , the Covi Anxiety Scale , and the Leeds Sleep Question naire . Additionally , scores for two items and five factors from the HAM-D were analyzed . RESULTS Efficacy was based on 124 evaluable patients in each treatment group . As measured by HAM-D and CGI-Severity scores , there was a significant ( p < .001 ) improvement from baseline to each follow-up visit in both treatment groups with no statistically significant difference between groups . There was also no significant difference in the proportion of responders in each group . CGI-Improvement responder rates were 69 % for sertraline and 67 % for fluoxetine . Results of secondary efficacy measurements followed the same trend , although from the second week of treatment there was a numerical advantage ( not statistically significant ) for sertraline over fluoxetine in improving anxiety symptoms as measured by the total HAM-A score . Headache and nausea were the most frequently reported events for both drugs . The incidence of early patient withdrawals due to treatment-emergent adverse events was 14 % for sertraline and 13 % for fluoxetine . The starting dosage ( sertraline 50 mg/day , fluoxetine 20 mg/day ) was the final dosage in 76 % of patients in both treatment groups . CONCLUSION Sertraline and fluoxetine were equally effective and well tolerated in patients with major depression and associated anxiety The efficacy and tolerability of moclobemide ( 300–600 mg daily ) and fluoxetine ( 20–40 mg daily ) were compared in a 6-week , double-blind study of 65 in patients and 34 out patients suffering from major depressive episodes ( DSM III-R ) . No statistically significant differences between the two treatment groups were noted regarding efficacy ( HDRS , CGI ) or safety ( adverse events , laboratory examination , vital signs ) . Moclobemide ( 300–600 mg daily ) and fluoxetine ( 20–40 mg daily ) would thus appear to be comparable both in antidepressant efficacy and tolerability . Doubling the low dosage in non-responders after 3 weeks result ed in a statistically significant improvement of CGI in the moclobemide group by comparison with the fluoxetine group at study end , suggesting that 600 mg moclobemide/day can still improve the patient 's condition , while 40 mg fluoxetine/day does not . Sexual dysfunction was reported in two patients taking fluoxetine Whether fluoxetine ( FX ) is effective in the treatment of  anxious depression  is still debated . In the present study , after one week of placebo ( single blind ) , 142 out patients affected by major depression with relevant anxiety and agitation were r and omly assigned ( double blind ) to either FX ( 20 mg/day ) ( n. 67 ) or amitriptyline ( AM ) ( daily dose : 115+/-39.2 mg ) ( n.75 ) for a period of 10 weeks . Between groups , the mean score of Hamilton Rating Scale for Depression ( HRSD ) was significantly different only after 3 weeks of treatment ( AM 14.7+/-5.7 vs FX 17.3+/-6.2 ( p = 0.02 ) , whereas at the end of the trial it was similar ( AM 8.15+/-6.9 ; FX 8.96+/-6.6 ) . At each visit , no significant difference between groups was found regarding the scores of the HRSD items " psychic anxiety " , " somatic anxiety " , " agitation " . Furthermore , the FIX treatment did not increase the scores of the items " suicide " , " psychic anxiety " , " somatic anxiety " , " agitation " and " insomnia " . These findings suggest that patients affected by major depression with anxiety and /or agitation were effectively and safely treated with FX without increasing risks 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 . The efficacy and tolerability of moclobemide ( 300 or 600 mg daily ) and fluoxetine ( 20 or 40 mg daily ) were compared in a 6-week , double-blind study of 25 in patients and 24 out patients who had major depressive episodes without psychotic features ( DSM-III-R ) . Although the clinical results of this study suggest better efficacy with moclobemide and better tolerability with fluoxetine , a statistically significant difference between treatment groups was noted only with respect to Clinical Global Impressions recorded after 10 days of therapy ; these were significantly better in the moclobemide group . A daily dosage of 300 mg of moclobemide and 20 mg of fluoxetine would thus appear to be comparable both in antidepressant efficacy and tolerability One hundred and eighty three patients with DSM-III-R major depressive illness were allocated r and omly to treatment with one of two new generation antidepressants , fluoxetine and lofepramine . Both patient groups had significantly lower mean scores on the Hamilton Depression Rating Scale ( HDRS ) 6 weeks after entry to the trial ( p < 0.001 ) , but there were no differences between the groups , either at baseline or after 6 weeks , in total HRDS score or in subscores for anxiety or suicidality . Anticholinergic side effects were commoner with lofepramine ; adverse effects were on the whole mild and few patients dropped out because of them . This study does not support previous cl aims of specific adverse effects of fluoxetine on anxiety and suicidality
target: A metaregression analysis indicated that , after adjusting for possible confounders , studies where fluoxetine was the experimental agent were positively associated with treatment effect , indicating a significant advantage for fluoxetine .
  The evidence that the outcome of fluoxetine trials varied according to whether this drug was used as a new compound or a reference one suggests the presence of bias
background: The present study investigated whether the outcome of r and omized clinical trials study ing fluoxetine favored fluoxetine , where this was the experimental agent , and favored comparator antidepressants in trials where fluoxetine was the reference agent .