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Maurizio Fava - One of the best experts on this subject based on the ideXlab platform.
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pretreatment reward sensitivity and frontostriatal resting state functional connectivity are associated with response to bupropion after Sertraline nonresponse
Biological Psychiatry, 2020Co-Authors: Yuensiang Ang, Maurizio Fava, Roselinde H Kaiser, Thilo Deckersbach, Jorge R C Almeida, Mary L Phillips, Henry W Chase, Christian A Webb, Ramin V Parsey, Patrick J McgrathAbstract:Abstract Background Standard guidelines recommend selective serotonin reuptake inhibitors as first-line antidepressants for adults with major depressive disorder, but success is limited and patients who fail to benefit are often switched to non–selective serotonin reuptake inhibitor agents. This study investigated whether brain- and behavior-based markers of reward processing might be associated with response to bupropion after Sertraline nonresponse. Methods In a two-stage, double-blinded clinical trial, 296 participants were randomized to receive 8 weeks of Sertraline or placebo in stage 1. Individuals who responded continued on another 8-week course of the same intervention in stage 2, while Sertraline and placebo nonresponders crossed over to bupropion and Sertraline, respectively. Data from 241 participants were analyzed. The stage 2 sample comprised 87 patients with major depressive disorder who switched medication and 38 healthy control subjects. A total of 116 participants with major depressive disorder treated with Sertraline in stage 1 served as an independent replication sample. The probabilistic reward task and resting-state functional magnetic resonance imaging were administered at baseline. Results Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not Sertraline. Null findings for Sertraline were replicated in the stage 1 sample. Conclusions Pretreatment reward sensitivity and frontostriatal connectivity may identify patients likely to benefit from bupropion following selective serotonin reuptake inhibitor failures. Results call for a prospective replication based on these biomarkers to advance clinical care.
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fluoxetine versus Sertraline and paroxetine in major depressive disorder changes in weight with long term treatment
The Journal of Clinical Psychiatry, 2000Co-Authors: Maurizio Fava, Sharon L Hoog, Rajinder Judge, Mary E Nilsson, Stephanie C KokeAbstract:BACKGROUND The effects of extended selective serotonin reuptake inhibitor (SSRI) treatment on weight are not well characterized. Also unknown is whether different agents have differential effects. To examine these questions, we assessed weight changes in patients randomly assigned to long-term treatment with fluoxetine, Sertraline, or paroxetine. METHOD Patients (N = 284) with major depressive disorder (DSM-IV) were randomly assigned to double-blind treatment with fluoxetine (N = 92), Sertraline, (N = 96), or paroxetine (N = 96) for a total of 26 to 32 weeks. The mean percent change in weight was compared for each group, as was the number of patients who had > or = 7% weight increase from baseline. RESULTS Patients (fluoxetine, N = 44; Sertraline, N = 48; paroxetine, N = 47) who completed the trial were included in these analyses. Paroxetine-treated patients experienced a significant weight increase, fluoxetine-treated patients had a modest but nonsignificant weight decrease, and patients treated with Sertraline had a modest but nonsignificant weight increase. The number of patients whose weight increased > 7% from baseline was significantly greater for paroxetine-treated compared with either fluoxetine-treated or Sertraline-treated patients. CONCLUSION Risk of weight gain during extended SSRI treatment differs depending on which SSRI is used.
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interruption of selective serotonin reuptake inhibitor treatment double blind placebo controlled trial
British Journal of Psychiatry, 2000Co-Authors: David Michelson, Jay D Amsterdam, Maurizio Fava, Jeffrey T Apter, Peter Londborg, Roy N Tamura, R TepnerAbstract:Background Abrupt interruption of therapy with selective serotonin reuptake inhibitors (SSRIs) has been associated with somatic and psychological symptoms. Aims Systematically to assess symptoms and effects on daily functioning related to interruption of SSRI therapy. Method Patients treated with fluoxetine, setraline or paroxetine underwent identical five-day periods of treatment interruption and continued active treatment under double-blind, order-randomised conditions, with regular assessment of new symptoms. Results Placebo substitution for paroxetine was associated with increases in the number and severity of adverse events following the second missed dose, and increases in functional impairment at five days. Placebo substitution for Sertraline resulted in less pronounced changes, while interruption of fluoxetine was not associated with any significant increase in symptomatology. Conclusions Abrupt interruption of SSRI treatment can result in a syndrome characterised by specific physical and psychological symptoms. Incidence, timing and severity of symptoms vary among SSRIs in a fashion that appears to be related to plasma elimination characteristics.
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selective serotonin reuptake inhibitor discontinuation syndrome a randomized clinical trial
Biological Psychiatry, 1998Co-Authors: Jerrold F Rosenbaum, Maurizio Fava, Sharon L Hoog, Richard C Ascroft, William B KrebsAbstract:Background: Recent reports describe discontinuation-emergent adverse events upon cessation of selective serotonin reuptake inhibitors including dizziness, insomnia, nervousness, nausea, and agitation. We hypothesized that interruption of fluoxetine treatment would be associated with fewer discontinuation-emergent adverse events than interruption of Sertraline or paroxetine treatment, based on fluoxetine’s longer half-life. Methods: In this 4-week study, 242 patients with remitted depression receiving maintenance therapy with open-label fluoxetine, Sertraline, or paroxetine for 4–24 months had their maintenance therapy interrupted with double-blind placebo substitution for 5–8 days. The Symptom Questionnaire (SQ), the Discontinuation-Emergent Signs and Symptoms checklist, the 28-item Hamilton Depression Rating Scale, and the Montgomery–Asberg Depression Rating Scale were used to assess somatic distress and stability of antidepressant response. Results: Two hundred twenty patients (91%) completed the study. Following interruption of therapy, fluoxetine-treated patients experienced fewer discontinuation-emergent events than either Sertraline-treated or paroxetine-treated patients (p < .001). The mean SQ somatic symptom scale score in fluoxetine-treated patients was significantly lower than that in Sertraline-treated and paroxetine-treated patients (p < .001). Fluoxetine-treated patients also experienced less reemergence of depressive symptoms than Sertraline-treated or paroxetine-treated patients (p < .001). Conclusions: Abrupt interruption of antidepressant therapy for 5–8 days was associated with the emergence of new somatic and psychological symptoms in patients treated with paroxetine and to a lesser degree Sertraline, with few symptoms seen with fluoxetine.
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a placebo controlled randomized clinical trial comparing Sertraline and imipramine for the treatment of dysthymia
Archives of General Psychiatry, 1996Co-Authors: Michael E Thase, Lorrin M. Koran, James H Kocsis, Jonathan R. T. Davidson, Uriel Halbreich, Jerrold F Rosenbaum, Maurizio Fava, Wilma HarrisonAbstract:Background: Despite the high prevalence of dysthymia and its associated morbidity, few controlled trials have evaluated the efficacy of antidepressant medication for this disorder. A 12-week, double-blind, placebo-controlled, randomized, multicenter trial was performed to evaluate the safety and efficacy of Sertraline hydrochloride and imipramine hydrochloride in treating dysthymia. Methods: A total of 416 outpatients (271 women and 145 men) aged 25 to 65 years with DSM-III-R -difined, early-onset, primary dysthymia without concurrent major depression were randomized to 12 weeks of treatment with Sertraline, imipramine, or placebo. Results: Both active treatments resulted in significantly reduced scores on the 17-item Hamilton Rating Scale for Depression ( P =.04 and P =.01 for Sertraline and imipramine vs placebo, respectively), the Montgomery Asberg Depression Rating Scale ( P =.01 and P =.003 vs pIacebo, respectively), Hopkins Symptom Checklist ( P P P =.02 for Sertraline vs placebo and P P =.001 and P Conclusions: Pharmacotherapy provides considerable relief from the symptoms of dysthymia in patients suffering from this chronic affective disorder, with both Sertraline and imipramine being more effective than pIacebo. The greater tolerability of Sertraline is an important consideration because of the chronicity of dysthymia, which may require prolonged treatment with antidepressant medication.
Wilma Harrison - One of the best experts on this subject based on the ideXlab platform.
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a double blind placebo controlled study comparing the effects of Sertraline versus amitriptyline in the treatment of major depression
The Journal of Clinical Psychiatry, 1997Co-Authors: R B Lydiard, S Stahl, M Hertzman, Wilma HarrisonAbstract:Background: This study was designed to compare the efficacy, safety, tolerability profiles, and effects on quality of life of the serotonin selective reuptake inhibitor antidepressant Sertraline versus the nonselective tricyclic antidepressant amitriptyline and placebo in patients with major depression. Method: Outpatients with DSM-III-R major depression were randomly assigned to double-blind treatment for 8 weeks with Sertraline (50-200 mg daily), amitriptyline (50-150 mg daily), or matching placebo. Assessments included the Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions-Severity of Illness scale, Clinical Global Impressions-Improvement scale, Global Assessment Scale, Profile of Mood States, Beck Depression Inventory, Quality of Life Enjoyment and Satisfaction Questionnaire, and Health-Related Quality of Life battery. Results: All treatment groups demonstrated statistically significant improvement from baseline in depression ratings by Week I and thereafter. The antidepressant effects of amitriptyline and Sertraline were significantly (p <.05) greater than placebo and did not differ significantly from each other. Sertraline was associated with significantly (p <.05) greater subjective (i.e., patient-rated) improvement in mood than amitriptyline or placebo. Both active drugs were associated with greater improvements than placebo on most quality of life measurements. On several items, Sertraline, but not amitriptyline, was superior to placebo. There was a discernible effect of Sertraline earlier than amitriptyline on most quality of life scales. Amitriptyline therapy was associated with significantly more treatment-related adverse events, and discontinuations due to treatment-related adverse events, in comparison to both Sertraline and placebo therapy. Conclusion: Sertraline and amitriptyline each were effective treatments for major depression as assessed by both physician- and patient-rated scales. These results show that Sertraline therapy is better tolerated than amitriptyline therapy. Quality of life was also improved by effective antidepressant treatment, with Sertraline showing a tendency to produce greater improvements on quality of life measures.
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desipramine pharmacokinetics when coadministered with paroxetine or Sertraline in extensive metabolizers
Journal of Clinical Psychopharmacology, 1997Co-Authors: Jeffrey Alderman, Sheldon H. Preskorn, Wilma Harrison, David J Greenblatt, Darryl Penenberg, Janet Allison, Menger ChungAbstract:In vitro studies have shown that fluoxetine and paroxetine are more potent inhibitors of cytochrome CYP2D6 than Sertraline. The pharmacokinetics of desipramine when coadministered with the selective serotonin reuptake inhibitors (SSRIs) paroxetine and Sertraline were studied in 24 healthy male volunteers (CYP2D6 extensive metabolizers). Desipramine (50 mg/day) was administered for 23 days in each phase of the crossover study with a 7-day drug-free period between phases. In addition, subjects were randomly assigned to receive concomitant paroxetine (20 mg/day on days 8 through 17 followed by 30 mg/day on days 18 through 20) or Sertraline (50 mg/day on days 8 through 17 and 100 mg/day on days 18 through 20). SSRI treatments were switched between phases. After 10 days of coadministration at the lower dose, mean desipramine maximum concentration in plasma (Cmax) relative to baseline increased from 37.8 to 173 ng/mL (+358%) with paroxetine versus from 36.1 to 51.9 ng/mL (+44%) with Sertraline; the mean desipramine 24-hour area under the concentration-time curve (AUC[24]) increased from 634 to 3,305 ng x h/mL (+421%) with paroxetine versus from 611 to 838 ng x h/mL (+37%) with Sertraline; and the mean desipramine trough value (C0) increased from 18.5 to 113 ng/mL (+511%) with paroxetine versus from 18.3 to 21.8 ng/mL (+19%) with Sertraline (all increases, p < 0.001). An approximately 10-fold increase in the Cmax and AUC(24) of paroxetine and an approximately 2-fold increase in these parameters for Sertraline occurred simultaneously with the desipramine concentration changes. Thus, when coadministered with 50 mg/day desipramine, Sertraline had significantly less pharmacokinetic interaction than paroxetine with desipramine at the recommended starting dosages of 50 mg/day and 20 mg/day, respectively.
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a placebo controlled randomized clinical trial comparing Sertraline and imipramine for the treatment of dysthymia
Archives of General Psychiatry, 1996Co-Authors: Michael E Thase, Lorrin M. Koran, James H Kocsis, Jonathan R. T. Davidson, Uriel Halbreich, Jerrold F Rosenbaum, Maurizio Fava, Wilma HarrisonAbstract:Background: Despite the high prevalence of dysthymia and its associated morbidity, few controlled trials have evaluated the efficacy of antidepressant medication for this disorder. A 12-week, double-blind, placebo-controlled, randomized, multicenter trial was performed to evaluate the safety and efficacy of Sertraline hydrochloride and imipramine hydrochloride in treating dysthymia. Methods: A total of 416 outpatients (271 women and 145 men) aged 25 to 65 years with DSM-III-R -difined, early-onset, primary dysthymia without concurrent major depression were randomized to 12 weeks of treatment with Sertraline, imipramine, or placebo. Results: Both active treatments resulted in significantly reduced scores on the 17-item Hamilton Rating Scale for Depression ( P =.04 and P =.01 for Sertraline and imipramine vs placebo, respectively), the Montgomery Asberg Depression Rating Scale ( P =.01 and P =.003 vs pIacebo, respectively), Hopkins Symptom Checklist ( P P P =.02 for Sertraline vs placebo and P P =.001 and P Conclusions: Pharmacotherapy provides considerable relief from the symptoms of dysthymia in patients suffering from this chronic affective disorder, with both Sertraline and imipramine being more effective than pIacebo. The greater tolerability of Sertraline is an important consideration because of the chronicity of dysthymia, which may require prolonged treatment with antidepressant medication.
Dwayne D Callwood - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of Sertraline for depression in patients with heart failure results of the sadhart chf Sertraline against depression and heart disease in chronic heart failure trial
Journal of the American College of Cardiology, 2010Co-Authors: Christopher M Oconnor, Wei Jiang, Maragatha Kuchibhatla, Susan G Silva, Michael S Cuffe, Dwayne D Callwood, Bosh Zakhary, Wendy Gattis StoughAbstract:Objectives The objective was to test the hypothesis that heart failure (HF) patients treated with Sertraline will have lower depression scores and fewer cardiovascular events compared with placebo. Background Depression is common among HF patients. It is associated with increased hospitalization and mortality. Methods The SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial was a randomized, double-blind, placebo-controlled trial of Sertraline 50 to 200 mg/day versus matching placebo for 12 weeks. All participants also received nurse-facilitated support. Eligible patients were age 45 years or older with HF (left ventricular ejection fraction ≤45%, New York Heart Association functional class II to IV) and clinical depression (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria for current major depressive disorder). Those with significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medications were excluded. Primary end points were change in depression severity (Hamilton Depression Rating Scale total score) and composite cardiovascular status at 12 weeks. Results A total of 469 patients were randomized (n = 234 Sertraline, n = 235 placebo). The mean ± SE change from baseline to 12 weeks in the Hamilton Depression Rating Scale total score was −7.1 ± 0.5 (Sertraline) and −6.8 ± 0.5 (placebo) (p Conclusions Sertraline was safe in patients with significant HF. However, treatment with Sertraline compared with placebo did not provide greater reduction in depression or improved cardiovascular status among patients with HF and depression. (Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure [SADHART-CHF]; NCT00078286 )
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safety and efficacy of Sertraline for depression in patients with heart failure results of the sadhart chf Sertraline against depression and heart disease in chronic heart failure trial
Journal of the American College of Cardiology, 2010Co-Authors: Christopher M Oconnor, Wei Jiang, Maragatha Kuchibhatla, Susan G Silva, Michael S Cuffe, Dwayne D Callwood, Bosh Zakhary, Wendy Gattis StoughAbstract:Objectives The objective was to test the hypothesis that heart failure (HF) patients treated with Sertraline will have lower depression scores and fewer cardiovascular events compared with placebo. Background Depression is common among HF patients. It is associated with increased hospitalization and mortality. Methods The SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial was a randomized, double-blind, placebo-controlled trial of Sertraline 50 to 200 mg/day versus matching placebo for 12 weeks. All participants also received nurse-facilitated support. Eligible patients were age 45 years or older with HF (left ventricular ejection fraction ≤45%, New York Heart Association functional class II to IV) and clinical depression (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria for current major depressive disorder). Those with significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medications were excluded. Primary end points were change in depression severity (Hamilton Depression Rating Scale total score) and composite cardiovascular status at 12 weeks. Results A total of 469 patients were randomized (n = 234 Sertraline, n = 235 placebo). The mean ± SE change from baseline to 12 weeks in the Hamilton Depression Rating Scale total score was −7.1 ± 0.5 (Sertraline) and −6.8 ± 0.5 (placebo) (p < 0.001 from baseline, p = 0.89 between groups, mean change between groups −0.4; 95% confidence interval: −1.7 to 0.92). The proportions whose composite cardiovascular score worsened, improved, or was unchanged were 29.9%, 40.6%, and 29.5%, respectively, in the Sertraline group and 31.1%, 43.8%, and 25.1%, respectively, in the placebo group (p = 0.78). Conclusions Sertraline was safe in patients with significant HF. However, treatment with Sertraline compared with placebo did not provide greater reduction in depression or improved cardiovascular status among patients with HF and depression. (Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure [SADHART-CHF]; [NCT00078286][1]) [1]: http://www.clinicaltrials.gov/ct2/show/NCT00078286?term=NCT00078286%26rank=1
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safety and efficacy of Sertraline for depression in patients with chf sadhart chf a randomized double blind placebo controlled trial of Sertraline for major depression with congestive heart failure
American Heart Journal, 2008Co-Authors: Wei Jiang, Christopher M Oconnor, Maragatha Kuchibhatla, Susan G Silva, Michael S Cuffe, Dwayne D Callwood, Bosh Zakhary, Elizabeth Henke, Rebekka M AriasAbstract:Background Sertraline, a selective serotonin-reuptake inhibitor, has demonstrated substantial mood improvement in patients with post myocardial infarction or with unstable angina. The impact of Sertraline on the prognosis and depression of patients with chronic heart failure (HF) and comorbid major depressive disorder (MDD) is unknown. Method This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of Sertraline in the treatment of MDD in patients with HF. The study is designed also to examine the effects of treating depression on cardiac events and morbidity/mortality in patients with HF. Approximately 500 men and women who are ≥45 years of age with current MDD and chronic systolic HF, characterized by left ventricular ejection fraction ≤45% and New York Heart Association class ≥II, comprise the study population. Eligible participants are randomized to either Sertraline or placebo for a 12-week acute treatment phase. All patients, regardless of acute treatment phase completion, are followed routinely until the last subject completes 6-month follow-up. Quality of life and certain physiologic parameters, as well as pro-inflammatory and HF biomarkers, that may reflect the impact of Sertraline in this particular population are measured at baseline and at the end of the acute treatment phase. Conclusion Because of the high prevalence of depression and its significant adverse impact on prognosis of patients with ischemic heart disease (IHD) and HF, the Safety and Efficacy of Sertraline for Depression in Patients with Chronic Heart Failure (SADHART-CHF) trial aims to assess the effects of Sertraline on response of depression as well as on the cardiac prognosis of patients with HF.
Jay D Amsterdam - One of the best experts on this subject based on the ideXlab platform.
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rhodiola rosea versus Sertraline for major depressive disorder a randomized placebo controlled trial
Phytomedicine, 2015Co-Authors: Jun J Mao, Sharon X Xie, Jarcy Zee, Irene Soeller, Kenneth Rockwell, Jay D AmsterdamAbstract:Abstract Background: We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus Sertraline for mild to moderate major depressive disorder. Hypothesis: We hypothesize that R. rosea would have similar therapeutic effects as Sertraline but with less adverse events. Study design: Phase II randomized placebo controlled clinical trial. Methods: 57 subjects were randomized to 12 weeks of standardized R. rosea extract, Sertraline, or placebo. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores among groups were examined using mixed-effects models. Results: Modest, albeit statistically non-significant, reductions were observed for HAM-D, BDI, and CGI/C scores for all treatment conditions with no significant difference between groups (p = 0.79, p = 0.28, and p = 0.17, respectively). The decline in HAM-D scores was greater for Sertraline (−8.2, 95% confidence interval [CI], −12.7 to −3.6) versus R. rosea (−5.1, 95% CI: −8.8 to −1.3) and placebo (−4.6, 95% CI: −8.6 to −0.6). While the odds of improving (versus placebo) were greater for Sertraline (1.90 [0.44–8.20]; odds ratio [95% CI]) than R. rosea (1.39 [0.38–5.04]), more subjects on Sertraline reported adverse events (63.2%) than R. rosea (30.0%) or placebo (16.7%) (p = 0.012). Conclusions: Although R. rosea produced less antidepressant effect versus Sertraline, it also resulted in significantly fewer adverse events and was better tolerated. These findings suggest that R. rosea, although less effective than Sertraline, may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression.
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genetic polymorphisms in the treatment of depression speculations from an augmentation study using atomoxetine
Psychiatry Research-neuroimaging, 2010Co-Authors: Frederick W Reimherr, David L Dunner, Jay D Amsterdam, David Michelson, Lenard A Adler, Shuyu Zhang, David A Williams, Barrie K Marchant, Andrew A Nierenberg, Alan F. SchatzbergAbstract:Treatment-resistant depression may be related to polymorphisms in the promoter region of the serotonin transporter gene (5-HTTLPR) or dysregulation of noradrenergic systems. To examine 5-HTTLPR genotypes and responses to treatment, adult patients (N=261) with current major depression and a symptom severity rating > or =8 on the 17-item Hamilton Depression Rating Scale (HAMD(17)) were treated for 8 weeks with open-label Sertraline (100-200 mg/d). Patients remaining symptomatic (total score >4, or >1 on any item of the HAMD(17) Maier-Philipp subscale) were randomly assigned to double-blind therapy with Sertraline plus either atomoxetine (40-120 mg/d) or placebo for 8 additional weeks. 5-HTTLPR genotype did not predict responses to Sertraline monotherapy or discontinuation rates. Among the 138 patients remaining symptomatic after Sertraline monotherapy (L/L = 21%, S/L = 50%, S/S = 29%), significantly more S/S-genotype patients achieved remission under combined Sertraline/atomoxetine treatment relative to the other genotypes (S/S = 81.8%; non-S/S = 32.7%), but not under Sertraline/placebo treatment (S/S = 35.7%; non-S/S = 37.7%). Minor genotypic differences were noted in adverse event profiles. In patients with poor responses to Sertraline monotherapy for depression, addition of atomoxetine may improve responses to treatment of depression in S/S-genotyped patients. Although this study is speculative, it represents a pharmacologically and genotypically well-defined patient population.
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efficacy and tolerability of adjunctive ziprasidone in treatment resistant depression a randomized open label pilot study
The Journal of Clinical Psychiatry, 2007Co-Authors: David L Dunner, Antony Loebel, Jay D Amsterdam, Richard C Shelton, S J RomanoAbstract:OBJECTIVE To evaluate the efficacy and tolerability of adjunctive ziprasidone in subjects with treatment-resistant major depressive disorder (DSM-IV criteria) without psychotic features. METHOD Subjects not responding to selective serotonin reuptake inhibitor (SSRI) monotherapy during a 6-week open-label trial were randomly assigned to continue monotherapy or receive adjunctive ziprasidone for 8 weeks in 1 of 3 groups: Sertraline 100 to 200 mg/day, Sertraline 100 to 200 mg/day plus ziprasidone 80 mg/day, or Sertraline 100 to 200 mg/day plus ziprasidone 160 mg/day. The trial was conducted from May 2001 to October 2002. Ziprasidone was administered twice daily. Primary efficacy measure was the least squares mean change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline of the 8-week phase to study end point. RESULTS In total, 64 subjects were randomly assigned to Sertraline monotherapy (N = 21), Sertraline plus ziprasidone 80 mg/day (N = 23), or Sertraline plus ziprasidone 160 mg/day (N = 20). Mean +/- SE improvement in MADRS total score on adjunctive ziprasidone 80 mg/day and ziprasidone 160 mg/day versus monotherapy, respectively, was -5.98 +/- 1.87 and -8.27 +/- 2.17 versus -4.45 +/- 2.03 (p = NS). Response rates for these groups were 19% (N = 4), 32% (N = 6), and 10% (N = 2), respectively (p = NS). No clinically significant changes were reported on physical examination, laboratory tests, or electrocardiogram on either adjunctive dose of ziprasidone. CONCLUSIONS In this preliminary study of antidepressant-resistant subjects with major depression, adjunctive ziprasidone was associated with greater clinical effect than was continued Sertraline monotherapy and was generally well tolerated. These data suggest that further controlled study of ziprasidone in treatment-resistant depression is warranted.
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interruption of selective serotonin reuptake inhibitor treatment double blind placebo controlled trial
British Journal of Psychiatry, 2000Co-Authors: David Michelson, Jay D Amsterdam, Maurizio Fava, Jeffrey T Apter, Peter Londborg, Roy N Tamura, R TepnerAbstract:Background Abrupt interruption of therapy with selective serotonin reuptake inhibitors (SSRIs) has been associated with somatic and psychological symptoms. Aims Systematically to assess symptoms and effects on daily functioning related to interruption of SSRI therapy. Method Patients treated with fluoxetine, setraline or paroxetine underwent identical five-day periods of treatment interruption and continued active treatment under double-blind, order-randomised conditions, with regular assessment of new symptoms. Results Placebo substitution for paroxetine was associated with increases in the number and severity of adverse events following the second missed dose, and increases in functional impairment at five days. Placebo substitution for Sertraline resulted in less pronounced changes, while interruption of fluoxetine was not associated with any significant increase in symptomatology. Conclusions Abrupt interruption of SSRI treatment can result in a syndrome characterised by specific physical and psychological symptoms. Incidence, timing and severity of symptoms vary among SSRIs in a fashion that appears to be related to plasma elimination characteristics.
Stephen M Stahl - One of the best experts on this subject based on the ideXlab platform.
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reemergence of sexual dysfunction in patients with major depressive disorder double blind comparison of nefazodone and Sertraline
The Journal of Clinical Psychiatry, 2001Co-Authors: James M Ferguson, Ram K Shrivastava, Stephen M Stahl, James T Hartford, Frances E Borian, John Ieni, Robert D Mcquade, Darlene JodyAbstract:Background: Several different classes of antidepressants have been associated with sexual adverse effects. This double-blind, randomized trial compared the effects of nefazodone and Sertraline on reemergence of sexual dysfunction in depressed patients who had experienced sexual dysfunction as a result of Sertraline treatment. Depressive symptoms were also monitored. Method: One hundred five patients with DSM-III-R major depressive episode who were experiencing sexual dysfunction attributable to Sertraline (100 mg/day) were screened for entry. Eligible patients entered a 1-week washout period that was followed by a 7- to 10-day single-blind placebo phase. Patients without symptoms of sexual dysfunction at the end of the single-blind placebo phase were randomly assigned to receive double-blind treatment with either nefazodone (400 mg/day) or Sertraline (100 mg/day) for 8 weeks. Results: Nearly 3 times more Sertraline-treated patients (76%; 25/33) experienced reemergence of sexual dysfunction (ejaculatory and/or orgasmic difficulty) than did nefazodone-treated patients (26%; 10/39) (p <.001). In addition, patients treated with nefazodone were more satisfied with their sexual functioning than were patients treated with Sertraline. Both treatment groups demonstrated a similar and sustained improvement in depressive symptoms. Both drugs were well tolerated, and the overall incidence of adverse reactions was similar for both treatment groups; however, 9 Sertraline-treated patients (26%) discontinued because of adverse events compared with 5 nefazodone-treated patients (12%). Of the patients discontinuing therapy for adverse events, 5 of the Sertraline-treated patients did so because of sexual dysfunction reported as an adverse event, whereas only 1 of the nefazodone-treated patients discontinued therapy secondary to sexual dysfunction. Conclusion: In this sample of patients with major depression who had recovered from sexual dysfunction induced by treatment with Sertraline, nefazodone treatment resulted in significantly less reemergence of sexual dysfunction than did renewed treatment with Sertraline and provided continued antidepressant activity.
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placebo controlled comparison of the selective serotonin reuptake inhibitors citalopram and Sertraline
Biological Psychiatry, 2000Co-Authors: Stephen M StahlAbstract:Abstract Background: Previous comparative studies of the selective serotonin reuptake inhibitors (SSRIs) have rarely included a placebo control group and have rarely demonstrated significant between-group differences. The study reported on here was a placebo-controlled comparison of the antidepressant effects of two SSRIs, citalopram and Sertraline. Methods: Three hundred twenty-three patients with DSM-IV–defined major depressive disorder were randomized to 24 weeks of double-blind treatment with citalopram (20–60 mg/day), Sertraline (50–150 mg/day), or a placebo. The primary efficacy measure was the Hamilton Depression Rating Scale (HAMD) and the primary statistical analysis was an analysis of variance comparing the change from baseline to the last observation carried forward in each treatment group. Results: Both citalopram and Sertraline produced significantly greater improvement than placebo on the HAMD, the Montgomery–Asberg Depression Rating Scale, and the Clinical Global Impression Scale. Significant improvement was observed at earlier timepoints in the citalopram group than the Sertraline group; however, Sertraline treatment was associated with increased gastrointestinal side effects and a tendency toward early discontinuation, and analyses that excluded early dropouts revealed similar acute efficacy for the two active treatments. The Hamilton Anxiety Scale demonstrated a significant anxiolytic effect of citalopram, but not Sertraline, relative to placebo. Conclusions: This study confirms the antidepressant efficacy of two SSRIs, citalopram and Sertraline. It is hypothesized that the more consistent evidence of antidepressant activity that was observed early in treatment in the citalopram group was related to more pronounced antianxiety effects and better tolerability upon initiation of therapy.
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multicenter double blind comparison of Sertraline and desipramine for concurrent obsessive compulsive and major depressive disorders
Archives of General Psychiatry, 2000Co-Authors: Rudolf Hoehnsaric, Stephen M Stahl, Philip T Ninan, Donald W Black, John H Greist, Bruce Lydiard, Susan L Mcelroy, John Zajecka, Douglass Chapman, Cathryn M ClaryAbstract:Background Serotonin reuptake inhibitors (SRIs) have demonstrated consistent efficacy in the treatment of obsessive-compulsive disorder (OCD), while agents that are primarily norepinephrine reuptake inhibitors have not. Comparable efficacy has been demonstrated for SRI and non-SRI antidepressants in uncomplicated major depressive disorder (MDD). This multicenter trial is the first comparison of an SRI (Sertraline) and a non-SRI antidepressant (desipramine) in the treatment of OCD with concurrent MDD. Methods One hundred sixty-six patients diagnosed using structured clinical interviews and recruited from 16 treatment sites were randomly assigned to double-blind treatment with either Sertraline (up to 200 mg/d) or desipramine (up to 300 mg/d) over 12 weeks. Measures of severity of OCD and MDD symptoms, as well as adverse effects of the medications, were monitored over the course of the treatment period. Results Patients assigned to Sertraline responded significantly better at end point on measures of OCD and MDD symptoms compared with patients assigned to desipramine. Sertraline was also associated with a significantly greater number of patients who achieved a "robust" improvement in OCD symptoms (≥40% reduction) compared with desipramine. More patients receiving desipramine than Sertraline discontinued treatment because of adverse events. Conclusions The SRI Sertraline was more effective in reducing MDD and OCD symptoms than the primarily norepinephrine reuptake inhibitor desipramine for patients with concurrent OCD and MDD.
