title: Pharmacokinetics and safety of duloxetine, a dual-serotonin and norepinephrine reuptake inhibitor. The pilot study. Do social functioning and symptoms improve with continuation antidepressant treatment of persistent depressive disorder? An observational study. Duloxetine in military posttraumatic stress disorder. Open‐Label Support for Duloxetine for the Treatment of Panic Disorder Duloxetine for premenstrual dysphoric disorder: a pilot study The efficacy of duloxetine in the treatment of premature ejaculation Treatment of seasonal affective disorder with duloxetine: an open-label study. Duloxetine treatment for women with premenstrual dysphoric disorder: a single-blind trial. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. Duloxetine in obese binge eater outpatients: preliminary results from a 12‐week open trial Duloxetine, dual serotonin and norepinephrine reuptake inhibitor, versus paroxetine, selective serotonin reuptake inhibitor, in the treatment for premature ejaculation Efficacy and tolerability of duloxetine in the treatment of patients with borderline personality disorder: a pilot study Duloxetine Augmentation in Resistant Obsessive-Compulsive Disorder: A Double-Blind Controlled Clinical Trial Duloxetine as adjunctive treatment to clozapine in patients with schizophrenia: a randomized, placebo-controlled trial A comparison of initial duloxetine dosing strategies in patients with major depressive disorder. Open-Label Study of Duloxetine for the Treatment of Obsessive-Compulsive Disorder Reboxetine Adjuvant Therapy in Patients With Schizophrenia Showing a Suboptimal Response to Clozapine: A 12-Week, Open-Label, Pilot Study Duloxetine treatment of dysthymia and double depression: an open-label trial. Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study Comparative study of the effects of venlafaxine and duloxetine on chemotherapy-induced peripheral neuropathy Clinical outcomes of patients with major depressive disorder treated with either duloxetine, escitalopram, fluoxetine, paroxetine, or sertraline What is an open label trial?
abstract: The pharmacokinetics and safety of duloxetine were evaluated in a single-blind , placebo-controlled , escalating multiple-dose study in 12 healthy male subjects . In the treatment group ( n = 8) , duloxetine was administered orally at a starting dose of 20 mg twice daily ( bid ) and escalated at weekly intervals to 30 mg bid , then to 40 mg bid . The observed plasma concentration-time data at all three dose levels were adequately described by a one-compartment model with a first-order absorption rate constant . The mean oral clearance , apparent volume of distribution , and half-life values were 114 L/h ( range : 44 to 218 L/h ) , 1943 L ( range : 803 to 3531 L ) , and 12.5 h ( range : 9.2 to 19.1 h ) , respectively . Somnolence , nausea , and dry mouth were observed following the initial dose , but they resolved with continuing drug administration . Duloxetine was not associated with clinical ly significant changes in blood pressure ( BP ) or heart rate ( HR ) measured in the st and ing position . However , in recumbent position , small increases in systolic ( < or = 9 mmHg ) and diastolic ( < or = 5 mmHg ) BP and small decreases in HR ( < or = 6 beats/min ) were observed . Abrupt discontinuation of duloxetine was associated with a small increase in mean HR ( < or = 12 beats/min ) . In 3 subjects , abrupt discontinuation was also associated with transient sleep disturbance . No clinical ly important changes in electrocardiograms , cardiac intervals , clinical laboratory tests , and neurological functions were observed . These results indicate that duloxetine exhibits linear pharmacokinetics with respect to dose and duration of treatment and that a multiple oral dose regimen starting at 20 mg bid and gradually escalating up to 40 mg bid was generally well tolerated This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer OBJECTIVE To determine efficacy of continued treatment with the serotonin norepinephrine reuptake inhibitor duloxetine on symptom reduction and functional improvement in out patients with dysthymia . METHOD Fifty out patients with DSM-IV-TR diagnosed dysthymia who had participated in a 10 week double-blind , placebo-controlled study of duloxetine received open treatment for three months . Nineteen duloxetine responders continued duloxetine , 24 patients initially treated with placebo started open duloxetine treatment , and 7 duloxetine non-responders were treated with desvenlafaxine or bupropion , selected by clinician choice . RESULTS Patients continuing duloxetine maintained symptom improvement , 84 % meeting response and 63 % remission criteria at week 22 . Patients initially treated with placebo showed similarly high levels of response ( 83 % ) and remission ( 62 % ) at week 22 , and most duloxetine non-responders subsequently responded to other antidepressants . Duloxetine-continuation patients improved modestly between weeks 10 and 22 on measures of social and cognitive functioning and temperament . Despite this improvement concurrently across several functional domains , 66.7 % of patients continuing duloxetine remained in the impaired range of functioning according to the Social Adjustment Scale ( SAS ) . CONCLUSIONS Continued duloxetine treatment appears to be effective in maintaining symptom response in dysthymic disorder , and has positive effects on social functioning . However , the majority of patients do not show normalization of functioning , even when controlling for remission status . Additional treatments should be considered to target residual impairments in social functioning in mood remitted patients with persistent depressive disorder The objective of this prospect i ve study was to assess the efficacy and tolerability of duloxetine in the treatment of in military veterans with posttraumatic stress disorder (PTSD).Twenty subjects were enrolled in this 12-week , open-label trial . Diagnosis and symptom severity were assessed with the Clinician Administered PTSD Scale ( CAPS ) . Depressive symptoms were assessed the Hamilton Depression Rating Scale . All subjects had a CAPS score of at least 60 at baseline . Subjects with lifetime history of psychotic disorders or bipolar illness were excluded . Fifteen participants completed 12 weeks of treatment , five dropped-out from the trial , 3 due to side effects . For patients who discontinued , missing values were estimated using " the last observation carried forward " method . Significant improvements were seen on : CAPS total and all subscales , depression and sleep measures . Most of the improvement was observed by week 2 of treatment . Nine participants ( 45 % ) were classified as responders , defined by 20 % or greater improvement on CAPS total score . The mean daily dose of duloxetine was 81 mg . The most common side effects were constipation ( 20 % ) diarrhea ( 25 % ) and nausea ( 20 % ) . Two subjects developed tachycardia , one withdrew from the trial due to this problem . Duloxetine had a fast onset of action and was effective in about half of the subjects , it was well tolerated in most subjects . These preliminary results in a difficult to treat population warrant the conduction of a double blind , placebo-controlled study of duloxetine in PTSD Panic disorder with or without agoraphobia is a common , often chronic and refractory anxiety disorder . Although a number of pharmacotherapies are now indicated for panic disorder , many patients do not respond to available interventions . We hypothesized that duloxetine , a serotonin‐norepinephrine reuptake inhibitor ( SNRI ) that has greater initial noradrenergic effects than venlafaxine , would have broad efficacy for individuals with panic disorder . Fifteen individuals with panic disorder with or without agoraphobia received 8 weeks of open label duloxetine flexibly dosed from 60 to 120 mg per day . Duloxetine treatment result ed in significant anxiolysis as measured by the primary outcome measure , the Panic Disorder Severity Scale ( PDSS ) ( paired t(df ) = 4.02(14 ) , P= 0.0013 ) , as well as measures of generalized anxiety , depression and quality of life ( all P < 0.05 ) . Although definitive conclusions are limited due to its small open‐label nature , this first prospect i ve study provides preliminary support for the efficacy of duloxetine for panic disorder and suggests larger r and omized controlled study is warranted Objective : Premenstrual dysphoric disorder ( PMDD ) is a complex clinical syndrome that is notoriously difficult to treat . The purpose of the present study was to provide preliminary data on the effectiveness of duloxetine in PMDD . Research design and methods : Fifty-five women with PMDD were treated with a 60 mg/day dosage of duloxetine for two menstrual cycles . Responses were assessed at first and second treatment cycle . Main outcome measures : Outcome measures included a visual analogue scale , the Zung Self-rating Scale for Depression , the Hamilton Depression Rating Scale , the Hamilton Anxiety Rating Scale and the Clinical Global Impressions Scale . Results : Fifty patients completed the trial . All had significant improvement of depression and anxiety and response , defined as a 50 % decrease in daily symptom scores , occurred in 39 ( 78 % ) patients . The effects of active treatment were marked by the first active cycle of menstruation . Conclusions : Duloxetine 60 mg/day was effective in reducing PMDD symptoms and generally well tolerated . Limitations of the study were open-label design and lack of placebo control . However , the results appeared to be strong and consistent across measures . Adverse events ( nausea , insomnia , poor appetite ) were low . Further studies are needed to confirm these results Abstract Aim : Though premature ejaculation ( PE ) has been overshadowed by current attention given to erectile dysfunction , it is the most widespread form of male sexual dysfunction . Delayed or inhibited ejaculation , a known side effect of selective serotonin reuptake inhibitors ( SSRIs ) , has made SSRIs potentially useful in the treatment of this disorder . In the present study , we examined the efficacy of duloxetine , an SSRI , in the treatment of PE . Method : The study included 20 married patients diagnosed with PE . The patients were r and omly assigned to two groups , duloxetine ( group I ) and placebo ( group II ) , each consisting of 10 patients . The effects on the ejaculatory function were estimated by the intravaginal ejaculation latency time . All patients were evaluated by using clinical global impression-improvement Scale ( CGI-I ) . Results : The increase in the intravaginal ejaculation latency time in the duloxetine group was statistically significant than that of placebo group . Of group I patients , four ( 40 % ) were considered as “ very much improved ” and four ( 40 % ) “ much improved ” by CGI-I and only one of group II patients ( 10 % ) showed “ much improved ” . Conclusion : Duloxetine appears to be superior to placebo in the pharmacological treatment of PE when administered on a chronic basis OBJECTIVE The aim of this observational study was to evaluate the effects of duloxetine in the treatment of seasonal affective disorder ( SAD ) . PATIENTS AND METHODS 26 SAD patients were treated with open-label duloxetine 60 - 120 mg per day over 8 weeks . Ratings included the Structured Interview Guide for the Hamilton Depression Rating Scale ( SAD version ; SIGH-SAD ) and the Clinical Global Impression ( CGI ) . To estimate treatment effects on social functioning in SAD we employed the Social Adaptation Self Evaluation Scale ( SASS ) , the Sheehan Disability Scale ( SDS ) , and assessment s of days lost due to illness and days with reduction in productivity . RESULTS Duloxetine led to a significant improvement ( p<0.001 ) of SIGH-SAD , CGI severity , SASS , and SDS scores . Days lost due to illness and days with reduction in productivity were significantly diminished during treatment ( p<0.001 ) . Treatment with duloxetine over 8 weeks yielded a response rate ( SIGH-SAD<50 % of baseline value ) of 80.8 % and a remission rate ( SIGH-SAD<8 ) of 76.9 % in the intention to treat sample . The drop-out rate due to side effects was 15.4 % . CONCLUSIONS Our preliminary results indicate that duloxetine might be effective and able to ameliorate the negative social consequences of SAD Premenstrual dysphoric disorder ( PMDD ) affects 3 - 8 % of women of reproductive age and is characterized by severe mood symptoms that cause important functional impairment . Serotonergic antidepressants appear to be an effective treatment for this disorder . The purpose of this study was to collect evidence on the efficacy and tolerability of duloxetine , a dual reuptake inhibitor of serotonin and norepinephrine , in the treatment of PMDD . We conducted a pilot , single-blind , non-controlled , fixed-dose trial . After two cycles for diagnosis confirmation , including a single-blind placebo cycle , 20 women with PMDD were treated continuously for three menstrual cycles with 60 mg/d duloxetine . The primary measure of the efficacy of treatment with duloxetine was the significant reduction in premenstrual symptoms demonstrated by the comparison between the mean Daily Record of Severity of Problems ( DRSP ) scores at baseline to endpoint ( p=0.0002 ) . Statistically significant symptom reduction was observed in the first treatment cycle and throughout all the treatment phase . Clinical response , defined as a reduction 50 % of baseline premenstrual symptoms , occurred in 65 % of subjects ( intention-to-treat population ) . Significant improvements were demonstrated by secondary measures , including reduction in self-rated functional impairment ( p=0.01 ) and improvement in quality of life ( p=0.04 ) . The main side-effects associated with duloxetine were dry mouth , nausea , drowsiness , insomnia , decreased appetite , decreased libido , and sweating . Duloxetine was effective and generally well tolerated in the treatment of PMDD . Further large-scale , double-blind , placebo-controlled studies are needed to evaluate duloxetine as an additional treatment strategy for the management of PMDD OBJECTIVE Numerous double-blind studies have assessed the efficacy of antidepressants in treating chronic depressive disorder , including dysthymic disorder , low- grade chronic depression . However , there are no double-blind , placebo-controlled studies of serotonin-norepinephrine reuptake inhibitors in chronic depressive disorder . METHOD Out patients with chronic depressive disorder , but without concurrent major depressive disorder ( MDD ) , were r and omly assigned to prospect i ve double-blind duloxetine ( beginning at 30 mg/d , increased to a maximum dose of 120 mg/d ) versus placebo for 10 weeks . Inclusion criteria were current DSM-IV-TR diagnosis of dysthymic disorder or depression not otherwise specified , age 18 - 75 years , and a Hamilton Depression Rating Scale ( HDRS ) score ≥ 12 . Exclusion criteria included current major depression . The study was conducted between August 2006 and December 2011 . HDRS , Cornell Dysthymia Rating Scale ( CDRS ) , Clinical Global Impressions ( CGI ) , Beck Depression Inventory ( BDI ) , Global Assessment of Functioning ( GAF ) , Social Adjustment Scale ( SAS ) , and other assessment s were administered at each visit . We hypothesized that duloxetine would be superior to placebo in ( 1 ) 24-item HDRS total score , ( 2 ) the percentage of subjects classified as responders and remitters , and ( 3 ) secondary measures ( CDRS , BDI , CGI ) . Response was defined as > 50 % decrease in 24-item HDRS and CGI-Improvement scale score of 1 or 2 ( " very much improved " or " much improved " ) . Remission was defined as HDRS-17 item score ≤ 4 and 0 on item 1 of the HDRS ( depressed mood ) . RESULTS 65 subjects were enrolled , of whom 57 began medication . They ranged in age from 19 to 70 years ( mean ± SD = 41.63 ± 11.22 ) and included 24 women and 33 men . Baseline 24-item HDRS score ( mean ± SD ) for both groups was 20.75 ± 4.92 . After 10 weeks , duloxetine-treated subjects had significantly lower 24-item HDRS scores than placebo-treated subjects ( time-by-drug group effect on analysis of variance : F1,55 = 9.43 , P = .003 ) . Responder and remitter analyses significantly favored duloxetine treatment . The response rate was 65.5 % for duloxetine versus 25.0 % for placebo ( χ(2)(1 ) = 9.43 , P = .003 ) ; and the remitter rate was 55.2 % for duloxetine versus 14.3 % for placebo ( χ(2)(1 ) = 10.46 , P = .002 ) . After 10 weeks , duloxetine-treated subjects did not differ significantly better from placebo-treated subjects on the SAS ( time-by-drug group effect on analysis of variance : F(1,46 ) = 0.35 , P = .555 ) or on the GAF ( time-by-drug group effect on analysis of variance : F(1,51 ) = .01 , P = .922 ) . CONCLUSIONS Results on the 24-item HDRS , CGI , and CDRS suggest that duloxetine is efficacious in acute treatment of chronic nonmajor depressive disorder . Response and remission rates also differed significantly , favoring duloxetine treatment , but BDI , GAF , and social functioning ( Social Adjustment Scale ) did not . Duloxetine appears to be effective in acute treatment of nonmajor chronic depression . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00360724 Attempts have been made to find appropriate drug regimens to treat binge eating disorder ( BED ) . Several reports have examined the use of selective serotonin reuptake inhibitors ( SSRIs ) or mood stabilizers ; both serotonin and noradrenalin reuptake inhibitors ( SNRIs ) have been reported to be useful for binge eating , but the available data are limited . We evaluated the efficacy of duloxetine , an SNRI , in 45 obese patients who reported binge eating Abstract Purpose In the current analysis due to the mechanism of effect , we evaluated the treatment benefit of duloxetine 40 mg comparing with paroxetine 20 mg , based on its effects on personal distress and interpersonal difficulty related to ejaculation , perceived control over ejaculation , and satisfaction with sexual intercourse , as well as the patient-reported global impression of change in premature ejaculation ( PE ) and the effect on intravaginal ejaculatory latency times ( IELT ) in men with premature ejaculation . Material s and methods The study included 80 married male patients diagnosed with lifelong PE . A total of 80 patients were r and omly distributed into two groups of 40 patients each . Group 1 patients received 40 mg duloxetine once a day for a month . Group 2 patients received 20 mg paroxetine once a day for a month . International index of erectile function question naire ( IIEF ) and IELT and PE profile were recorded before and after treatment . Results Comparing the groups ’ mean treatment IELT , there was no difference between groups . The IELT increase from baseline to treatment was 117 % in the duloxetine group ( P < 0.001 ) and 126 % in the paroxetine group ( P < 0.001 ) . There was no statistical difference between two groups in terms of IELT increase ( P > 0.05 ) . Also , there was no statistically significant difference between two groups at baseline IIEF to treatment IIEF scores . All PEP measures improved significantly with duloxetine and paroxetine groups ( P < 0.001 ) . Conclusion We think that duloxetine is safe and effective for the treatment for premature ejaculation Guidelines of the American Psychiatric Association for borderline personality disorder ( BPD ) indicate selective serotonin reuptake inhibitors and the serotonin and noradrenaline reuptake inhibitor ( SNRI ) venlafaxine for treating affective dysregulation and impulsive behavioural dyscontrol symptoms . The SNRI duloxetine has been studied in patients with major depression , generalized anxiety disorder and fibromyalgia , showing particular efficacy on somatic complaints . This study investigates duloxetine in the treatment of patients with BPD . Eighteen out patients with a DSM-IV-TR diagnosis of BPD were treated with open-label duloxetine , 60 mg/day , for 12 weeks . Patients were assessed at baseline , week 4 and 12 with the CGI Severity item , the BPRS , the HAM-D , the HAM-A , the SOFAS , the BPD Severity Index ( BPDSI ) and the HSCL-90-Somatization Subscale ( HSCL-90 SOM ) . Adverse effects were evaluated using the Dosage Record Treatment Emergent Symptom Scale . Statistics were performed with the analysis of variance . Significant P values were ≤0.05 . Fourteen patients completed the study . Four patients ( 22.2 % ) discontinued treatment in the first 4 weeks because of non-compliance . A significant change was found for : BPRS , HAM-D , SOFAS , BPDSI total score and items ‘ impulsivity ’ , ‘ outbursts of anger ’ and ‘ affective instability ’ and HSCL-90 SOM . Adverse effects were mild headache and nausea . Initial results suggest that duloxetine is an effective and well-tolerated treatment for BPD , with positive effects on somatic symptoms Introduction The aim of this study is to evaluate the efficacy of duloxetine augmentation in treatment of resistant obsessive-compulsive disorder ( OCD ) . Methods This augmentation trial was design ed as an 8-week r and omized controlled , double-blind study . Forty-six patients experiencing OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor ( fluoxetine , citalopram , or fluvoxamine ) were r and omly allocated to receive duloxetine or sertraline plus their current anti-OCD treatment . The Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) was the primary outcome measure . Treatment response was defined as 25 % or more decrease in scores of Y-BOCS . The mean dosage of duloxetine was 44.4 mg/d ( range , 20–60 mg/d ) , and the mean dosage of sertraline was 123.8 mg/d ( range , 50–200 mg/d ) . Results Forty-six patients ( 24 of 30 in duloxetine group and 22 of 27 in sertraline group ) completed the trial . Both groups showed improvement during the 8-week study period ( mean Y-BOCS total score at week 8 as compared with baseline : P < 0.001 & P < 0.001 ) without significant difference ( P = 0.861 ) . Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0 % in Y-BOCS score , and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5 % in Y-BOCS . Discussion Our double-blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in patients with resistant OCD . However , it needs to be noted that our study is preliminary , and larger double-blind placebo-controlled studies are necessary to confirm the results Antidepressant drugs have often been used as an augmentation strategy for those patients who have demonstrated a suboptimal response to clozapine . The present 16-week double-blind , r and omized , placebo-controlled trial study aim ed to explore the efficacy and tolerability of duloxetine add-on pharmacotherapy on clinical symptomatology and executive cognitive functioning in a sample of patients with treatment-resistant schizophrenia receiving clozapine .  After clinical and neurocognitive assessment s , the patients were r and omly allocated to receive , in a double-blind design , at a dose of 60 mg per day of duloxetine or a placebo .  A final sample of 33 patients completed the study . The results obtained indicate that duloxetine added to stable clozapine treatment showed a beneficial effect on the negative and general psychopathological symptomatology in a sample of treatment-resistant schizophrenic patients . With regard to executive cognitive functions , duloxetine augmentation of clozapine had no significant effects . The findings provide evidence that duloxetine augmentation of clozapine treatment is safe and well tolerated and may be of benefit for patients who are partially responsive to clozapine monotherapy OBJECTIVE To compare the effects of starting doses of duloxetine taken with or without food on tolerability and efficacy in patients with major depressive disorder ( MDD ) . METHOD This double-blind , concurrent-dose-controlled , parallel- design trial contained a variable expected- duration placebo lead-in period and was conducted in adult out patients with DSM-IV-TR-defined MDD at psychiatric outpatient sites between October 2004 and January 2006 . In actuality , patients received placebo for 1 week and then were r and omly assigned to duloxetine 30 mg once daily in the morning ( q.a.m . ) ( N = 219 ) , 30 mg twice daily ( b.i.d . ) ( N = 213 ) , or 60 mg q.a.m . ( N = 215 ) for 1 week along with 1 of 2 instructions about food : take study drug with food or do not take within 1 hour of eating . For the remaining 5 weeks of acute treatment , all patients received 60 mg once daily . The primary objective was to compare incidence of treatment-emergent nausea at 30 mg q.a.m . versus 60 mg q.a.m . using item 112 ( nausea ) of the Association for Methodology and Documentation in Psychiatry adverse event scale ( AMDP-5 ) . Secondary outcome measures included mean change on AMDP-5 item 112 , discontinuations due to adverse events , mean changes in AMDP-5 items and subscales , spontaneously reported treatment-emergent adverse events , and vital signs . Efficacy was evaluated by the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) . RESULTS The primary analysis , which combined data from both food groups , showed no significant difference in the incidence of nausea between starting doses of 30 mg q.a.m . and 60 mg q.a.m . ( 23 % vs. 29 % , respectively ; p = .207 ) . However , mean changes on the AMDP-5 nausea item revealed a significant main effect of food ( p = .010 ) and a significant interaction between food and starting dose ( p = .033 ) . The food-by-dose interaction indicated that the benefit from taking drug with food was greatest in patients started at 60 mg q.a.m . , and the benefit of starting at 30 mg q.a.m . was greatest in patients taking drug without food . In patients who took study drug without food , there was a significant difference across initial-dose groups for discontinuation due to adverse events ( 30 mg q.a.m . = 3.6 % , 30 mg b.i.d . = 14.0 % , 60 mg q.a.m . = 10.2 % ; 30 mg q.a.m . vs. 30 mg b.i.d . , p = .008 ; 30 mg q.a.m . vs. 60 mg q.a.m . , p = .066 ) ; however , in patients who took study drug with food , discontinuations due to adverse events did not significantly differ ( 30 mg q.a.m . = 5.4 % , 30 mg b.i.d . = 7.5 % , 60 mg q.a.m . = 7.4 % ; all p values > .50 ) . Patients who started at 30 mg b.i.d . or 60 mg q.a.m . without food did not differ regarding mean changes ( i.e. , increases ) in the common adverse events score after 1 week of treatment but had significantly greater mean changes than patients who started at 30 mg q.a.m . without food ( 0.87 , 0.82 , and 0 , respectively ; p < .05 vs. 30 mg b.i.d . and 60 mg q.a.m . ) . No significant differences were found between initial-dose groups in vital signs . CONCLUSIONS These data imply that starting dulox-etine at 30 mg q.a.m . for 1 week with or without food or starting duloxetine at the therapeutic dose of 60 mg q.a.m . with food can improve the initial tolerability of the medication . Adding this information to existing knowledge of duloxetine will enable the clinician to tailor therapy most appropriately for the individual patient . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT 00191061 Background : This study sought to investigate the efficacy of duloxetine for the treatment of obsessive-compulsive disorder ( DSM-IV ) . Methods : Twenty individuals were enrolled in a 17-week , open-label trial of duloxetine at Massachusetts General Hospital . Data were collected between March 2007 and September 2012 . Study measures assessing obsessive-compulsive disorder symptoms , quality of life , depression , and anxiety were administered at baseline and weeks 1 , 5 , 9 , 13 , and 17 . The primary outcome measures were the Yale-Brown Obsessive Compulsive Scale and Clinical Global Improvement scale . Results : For the 12 study completers , pre- and posttreatment analyses revealed significant improvements ( P<.05 ) on clinician- and self-rated measures of obsessive-compulsive disorder symptoms and quality of life . Among the 12 completers , more than one-half ( n=7 ) satisfied full medication response criteria . Intention-to-treat analyses ( n=20 ) showed similar improvements ( P<.05 ) on primary and secondary study outcome measures . Conclusion : The results of this study suggest that duloxetine may provide a significant reduction in symptoms for patients with obsessive-compulsive disorder . Clinical Trials.gov NCT00464698 ; http:// clinical trials.gov/ct2/show/NCT00464698?term=NCT00464698&rank=1 Abstract The present 12-week open-label uncontrolled trial was aim ed to explore the efficacy of reboxetine add-on pharmacotherapy on clinical symptoms and cognitive functioning in 15 patients with schizophrenia with suboptimal response ( mean [ SD ] Brief Psychiatric Rating Scale baseline total score , 32.2 [ 5.4 ] ) despite receiving clozapine monotherapy at the highest tolerated dosage . The results obtained evidence d that reboxetine at a dosage of 4 mg/d mildly reduced only depressive symptoms ( Calgary Depression Scale for Schizophrenia : P = 0.035 , Cohen d = 0.7 ) , whereas worsening of performances on phonemic fluency ( P = 0.012 , Cohen d = 0.5 ) was observed . After Bonferroni correction , changes at the Calgary Depression Scale for Schizophrenia and at the Verbal Fluency Task were not further confirmed . The results obtained indicate that reboxetine seemed to be scarcely effective for reducing clinical symptoms in patients with schizophrenia who have had an incomplete clinical response to clozapine .  Regarding cognitive functioning , in our sample , a trend to experience cognitive impairment in the examined domains was observed , as confirmed by a mild worsening of performances on cognitive tasks . Schizophrenia is a heterogeneous disorder with regard to pathophysiology ; therefore , data reflecting the mean response of a sample of patients may fail to reveal therapeutic effects . More research is needed to better identify subgroups of patients with peculiar features , which may account for responsivity to experimental medications and augmentation strategies BACKGROUND Although not as common as major depressive disorder , dysthymia is not rare and is associated with substantial impairment . Antidepressants and some psychotherapies are often effective . We explored the efficacy of the antidepressant duloxetine , a serotonin and norepinephrine reuptake inhibitor . METHOD Between February 2005 and April 2006 , we recruited 24 adults with DSM-IV dysthymia or dysthymia and concurrent major depression ( " double depression " ) who had an entry score of > or = 17 on the clinician-rated Inventory for Depressive Symptomatology ( IDS-C ) . We excluded subjects with significant medical illnesses and those requiring other psychotropic agents or undergoing psychotherapy .  Subjects received duloxetine 60 mg/day for 6 weeks , increased as tolerated to 120 mg/day for the remainder of the 12-week trial for those with an inadequate treatment response . RESULTS The subjects ' mean + /- SD IDS-C scores decreased significantly from baseline ( 27.3 + /- 6.3 ) to endpoint ( 7.8 + /- 7.4 , Student t = 12.38 , df = 23 , p < or = .001 ) . The IDS-C response rate ( intent-to-treat [ ITT ] ) was 83 % ( 20/24 ) ; the remission rate ( ITT ) was 79 % ( 19/24 ) . Among study completers , these rates were 89 % ( 17/19 ) and 84 % ( 16/19 ) . Five subjects ( 21 % ) discontinued for side effects . CONCLUSION Duloxetine appears to be an effective and well-tolerated treatment for dysthymia and double depression . A double-blind , placebo-controlled study is under way . If duloxetine is found to be effective , studies powered to detect potential , clinical ly important differences between duloxetine and other antidepressants will be needed . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00185575 Objectives : Multimodal analgesia is widely advocated for the control of perioperative pain in an effort to reduce the use of opioid . Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with efficacy for chronic pain conditions . The primary objective of this study was to evaluate the efficacy of two 60 mg oral doses of duloxetine in terms of fentanyl consumption during the postoperative period in patients undergoing elective spine surgery . Material s and Methods : This study was prospect i ve , double-blind , r and omized , and placebo controlled . Patients received either 60 mg duloxetine or an identical placebo 1 hour before surgery and again the following morning . The study participants were allocated into 2 groups : Group C ( control ) participants received the placebo and Group D ( duloxetine ) participants received 60 mg duloxetine . The total consumption of fentanyl 48 hours after surgery was measured . Secondary end points were pain scores and the presence or absence of adverse effects , such as headache , nausea , vomiting , itching , dizziness , and drowsiness . Results : Demographic characteristics did not differ between groups . There was a significant difference in fentanyl consumption in the first 24 hours between Groups C and D ( mean difference , 223.11±39.32 µg ; P<0.001 ) . Fentanyl consumption also differed between Groups C and D after 48 hours ( mean difference , 179.35±32.55 µg ; P<0.000 ) . The pain scores over 48 hours did not significantly differ between groups . The incidence of side-effects was similar in both groups . Discussion : Duloxetine was effective as an adjunct for postoperative analgesia and reduced opioid consumption Objective One of the complications of chemotherapy is peripheral neuropathy . Various studies have shown that potent norepinephrine and serotonin reuptake inhibitors such as gabapentin , venlafaxine and duloxetine have therapeutic effects on neuropathy . The aim of this study was to compare the effects of venlafaxine vs. duloxetine on chemotherapy-induced peripheral neuropathy . Methods In this clinical trial , cancer patients who were suffering from chemotherapy-induced peripheral neuropathy comprised the study population . They were r and omly assigned to three pharmacotherapy groups including venlafaxine , duloxetine and placebo . Cranial , sensory , motor neuropathies as well as neuropathic pain were evaluated on day 1 , week 2 , and week 4 after enrollment . Results Grade of cranial , motor , sensory and neuropathic pain decreased significantly in venlafaxine and duloxetine groups . This reduction was more considerable in duloxetine group compared to venlafaxine group ( P < 0.05 ) . Conclusion Duloxetine seems to be more effective than venlafaxine in decreasing the symptoms of chemotherapy-induced peripheral neuropathy .  Duloxetine was more effective than venlafaxine in decreasing motor neuropathy and neuropathic pain grade Purpose To compare treatment outcomes in patients with major depressive disorder treated with duloxetine , escitalopram , fluoxetine , paroxetine , or sertraline for up to 6 months . Patients and methods Data were taken from a 6-month prospect i ve , observational study that included 1,549 major depressive disorder patients without sexual dysfunction in 12 countries . We report the overall results and those from Asian countries .  Depression severity was measured using the Clinical Global Impression and the 16-item Quick Inventory of Depressive Symptomatology Self-Report ( QIDS-SR16 ) . Clinical and functional remissions were defined as having a QIDS-SR16 < 6 , and as having a rating of <3 on all three Sheehan Disability Scale items and no reduced productivity , respectively . Mixed effects modeling with repeated measures analysis and generalized estimating equation models were used . Propensity scores were included in the models . Results The mixed effects modeling with repeated measures regression models showed that the Clinical Global Impression rating during follow-up was significantly lower in those patients treated with duloxetine compared with escitalopram ( 0.40 , 95 % CI 0.25 to 0.56 ) ; fluoxetine ( 0.22 , 95 % CI 0.05 to 0.38 ) ; paroxetine ( 0.38 , 95 % CI 0.23 to 0.54 ) ; and sertraline ( 0.32 , 95 % CI 0.16 to 0.49 ) . The QIDS-SR16 of duloxetine-treated patients was significantly lower than those treated with escitalopram ( 1.58 , 95 % CI 1.03 to 2.12 ) ; fluoxetine ( 1.48 , 95 % CI 0.90 to 2.06 ) ; paroxetine ( 1.53 , 95 % CI 1.00 to 2.07 ) ; and sertraline ( 1.19 , 95 % CI 0.61 to 1.78 ) . The probability of clinical remission of the patients treated with escitalopram , fluoxetine , paroxetine , and sertraline was lower than those treated with duloxetine ( OR 0.46 , 95 % CI 0.33 to 0.64 ; OR 0.42 , 95 % CI 0.29 to 0.61 ; OR 0.40 , 95 % CI 0.29 to 0.56 ; OR 0.50 , 95 % CI 0.35 to 0.71 ; respectively ) . The regression analysis of functional remission also showed more favorable results for duloxetine , with OR ranging from 0.43 , 95 % CI 0.31 to 0.60 for paroxetine to 0.49 , 95 % CI 0.35 to 0.70 for sertraline . The results for the Asian countries were generally consistent . Conclusion Duloxetine-treated patients had better 6-month outcomes in terms of depression severity and clinical and functional remission , compared with selective serotonin reuptake inhibitor-treated patients Research ers assessed the effectiveness of prazosin combined with scorpion antivenom in assisting recovery from scorpion sting . An open label r and omised controlled trial study design was used . The control treatment was prazosin alone . The setting was a hospital and research centre in Mahad , a region of India . Participants were patients with grade 2 scorpion envenomation , older than 6 months , and with no cardiorespiratory or central nervous system abnormalities . In total , 70 patients were recruited and allocated to treatment ( 35 to prazosin and scorpion antivenom , and 35 to prazosin alone ) by block r and omisation.1 The primary endpoint was resolution of the clinical syndrome within 10 hours of treatment , as assessed by the research ers . The secondary endpoints included the time needed for complete resolution of the clinical syndrome . The proportion of patients who showed complete resolution of the clinical syndrome within 10 hours of treatment was significantly greater in the prazosin plus antivenom group than in the prazosin alone group ( 91.4 % v 22.9 % ; difference 68.5 % , 95 % confidence interval 51.8 % to 85.2 % ; P<0.001 ) . The mean time needed for complete resolution of the clinical syndrome was significantly shorter in the antivenom plus prazosin group ( 8 v 17.7 h ; difference −9.7 h , −6.9 to −12.4 ) ; P<0.001 ) . The research ers concluded that recovery from a scorpion sting was hastened by simultaneous administration of scorpion antivenom plus prazosin compared with prazosin alone . Which of the following statements , if any , are true
target: Results : Duloxetine may be an effective treatment for mood spectrum disorders , panic disorder , several symptom clusters of borderline personality , and as add-on drug in schizophrenia .
  Modest or conflicting results have been found for the efficacy of duloxetine in obsessive-compulsive disorder , posttraumatic stress disorder , eating , and sexual disorders .
background: Background : Duloxetine hydrochloride ( DUL ) is an antidepressant included in the pharmacological class of serotonin-norepinephrine reuptake inhibitors approved for the treatment of major depressive disorder , generalized anxiety disorder , diabetic peripheral neuropathic pain , fibromyalgia , and chronic musculoskeletal pain .
  The aim of this review was to eluci date current evidence s on the use of DUL in the treatment of a variety of psychiatric disorders .