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Michael E Thase - One of the best experts on this subject based on the ideXlab platform.
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Continuation Phase treatment outcomes for switching, combining, or augmenting strategies for treatment‐resistant major depressive disorder: A VAST‐D report
Depression and anxiety, 2020Co-Authors: Sidney Zisook, Michael E Thase, Gary R. Johnson, Paul B. Hicks, Peijun Chen, Thomas Beresford, James P. Michalets, Sanjai Rao, James Allen Wilcox, Varadan SevilimeduAbstract:BACKGROUND This secondary analysis of the VA Augmentation and Switching Treatments for Depression study compared the Continuation Phase treatment outcomes of three commonly used second-step treatment strategies following at least one prior failed medication treatment attempt. METHODS In total, 1522 outpatients with MDD were randomized to switching to bupropion-SR (S-BUP), combining with bupropion-SR (C-BUP), or augmenting with aripiprazole (A-ARI). Following 12 weeks of acute Phase treatment, 725 entered the 24-week Continuation treatment Phase. Depressive symptom severity, relapse, "emergent" remission, anxiety, suicidal ideation, quality of life, health status, and side effects were compared. RESULTS We did not find clinically significant differential treatment effects with the exception that A-ARI was associated with less anxiety than S-BUP or C-BUP. Participants who entered Continuation treatment as remitters had milder depressive symptom severity and lower relapse rates than those not in remission; they also experienced more improvement on most other outcomes. A-ARI was associated with less anxiety, insomnia, and dry mouth but more somnolence, extrapyramidal effects, akathisia, abnormal laboratory values, and appetite and weight gain. CONCLUSIONS Continuation treatment is a dynamic period. Regardless of the treatment, participants who entered Continuation treatment at Week 12 in full remission continued to have better outcomes over the subsequent 24 weeks than those who were not in remission at the start of the Continuation Phase.
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Continuation Phase treatment outcomes for switching combining or augmenting strategies for treatment resistant major depressive disorder a vast d report
Depression and Anxiety, 2020Co-Authors: Sidney Zisook, Michael E Thase, Gary R. Johnson, Paul B. Hicks, Peijun Chen, Thomas Beresford, James P. Michalets, Sanjai Rao, James Allen Wilcox, Varadan SevilimeduAbstract:Background This secondary analysis of the VA Augmentation and Switching Treatments for Depression study compared the Continuation Phase treatment outcomes of three commonly used second-step treatment strategies following at least one prior failed medication treatment attempt. Methods In total, 1522 outpatients with MDD were randomized to switching to bupropion-SR (S-BUP), combining with bupropion-SR (C-BUP), or augmenting with aripiprazole (A-ARI). Following 12 weeks of acute Phase treatment, 725 entered the 24-week Continuation treatment Phase. Depressive symptom severity, relapse, "emergent" remission, anxiety, suicidal ideation, quality of life, health status, and side effects were compared. Results We did not find clinically significant differential treatment effects with the exception that A-ARI was associated with less anxiety than S-BUP or C-BUP. Participants who entered Continuation treatment as remitters had milder depressive symptom severity and lower relapse rates than those not in remission; they also experienced more improvement on most other outcomes. A-ARI was associated with less anxiety, insomnia, and dry mouth but more somnolence, extrapyramidal effects, akathisia, abnormal laboratory values, and appetite and weight gain. Conclusions Continuation treatment is a dynamic period. Regardless of the treatment, participants who entered Continuation treatment at Week 12 in full remission continued to have better outcomes over the subsequent 24 weeks than those who were not in remission at the start of the Continuation Phase.
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is sleep disturbance linked to short and long term outcomes following treatments for recurrent depression
Journal of Affective Disorders, 2020Co-Authors: Elaine M Boland, Michael E Thase, Jeffrey R. Vittengl, Lee Anna Clark, Robin B. JarrettAbstract:Abstract Background Pre-treatment sleep disturbance has been shown to predict antidepressant treatment outcomes. How changes in sleep disturbance during acute treatment affect longitudinal outcomes, or whether Continuation-Phase treatment further improves sleep disturbance, is unclear. Methods We assessed sleep disturbance repeatedly in: a) 523 adults with recurrent MDD who consented to 12–14 weeks of acute-Phase cognitive therapy (A-CT) and b) 241 A-CT responders at elevated risk for depression relapse/recurrence who were randomized to 8 months of Continuation-Phase treatment (C CT vs. fluoxetine vs. matched pill placebo) and followed protocol-treatment-free for 24 months. Trajectories of change in sleep and depression during and after A-CT were evaluated with multilevel models; individual intercepts and slopes were retained and input into Cox regression models to predict remission, recovery, relapse, and recurrence of MDD. Results Sleep disturbance improved over the course of A-CT, but most patients continued to report clinically significant sleep complaints. Response and remission were more likely in patients with less overall sleep disturbance and those with greater reduction in sleep disturbance during A-CT; these patients also achieved post-A-CT remission and recovery sooner. Sleep improvements endured throughout follow-up but were not enhanced by Continuation-Phase treatment. Sleep disturbance did not predict relapse or recurrence consistently. Limitations Objective sleep disturbance was not assessed. Analyses were not specifically powered to use sleep changes to predict outcomes. Conclusions Improvements in sleep disturbance during A-CT are linked to shorter times to remission and recovery, supporting consideration of monitoring and targeting sleep disturbance in adults with depression.
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initial steps to inform selection of Continuation cognitive therapy or fluoxetine for higher risk responders to cognitive therapy for recurrent major depressive disorder
Psychiatry Research-neuroimaging, 2017Co-Authors: Jeffrey R. Vittengl, Michael E Thase, Lee Anna Clark, Robin B. JarrettAbstract:Abstract Responders to acute-Phase cognitive therapy (A-CT) for major depressive disorder (MDD) often relapse or recur, but Continuation-Phase cognitive therapy (C-CT) or fluoxetine reduces risks for some patients. We tested composite moderators of C-CT versus fluoxetine's preventive effects to inform Continuation treatment selection. Responders to A-CT for MDD judged to be at higher risk for relapse due to unstable or partial remission ( N =172) were randomized to 8 months of C-CT or fluoxetine with clinical management and assessed, free from protocol treatment, for 24 additional months. Pre-Continuation-treatment characteristics that in survival analyses moderated treatments' effects on relapse over 8 months of Continuation-Phase treatment (residual symptoms and negative temperament) and on relapse/recurrence over the full observation period's 32 months (residual symptoms and age) were combined to estimate the potential advantage of C-CT versus fluoxetine for individual patients. Assigning patients to optimal Continuation treatment (i.e., to C-CT or fluoxetine, depending on patients' pre-Continuation-treatment characteristics) resulted in absolute reduction of relapse or recurrence risk by 16–21% compared to the other non-optimal treatment. Although these novel results require replication before clinical application, selecting optimal Continuation treatment (i.e., personalizing treatment) for higher risk A-CT responders may decrease risks of MDD relapse and recurrence substantively.
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Predictors of Longitudinal Outcomes after Unstable Response to Acute Phase Cognitive Therapy for Major Depressive Disorder
Psychotherapy (Chicago Ill.), 2015Co-Authors: Jeffrey R. Vittengl, Michael E Thase, Lee Anna Clark, Robin B. JarrettAbstract:After patients with major depressive disorder (MDD) respond to acute-Phase cognitive therapy (CT), Continuation-Phase treatments may be applied to improve long-term outcomes. We clarified which CT responders experience remission, recovery, relapse, and recurrence by testing baseline demographic, clinical, and personality variables. The sample of CT responders at higher risk of relapse (N = 241) was randomized to 8 months of Continuation-Phase CT, double-blinded fluoxetine, or pill placebo, and followed 24 months (Jarrett & Thase, 2010). Patients with lower positive emotionality and behavioral activation at the end of acute-Phase CT showed increased risk for relapse/recurrence of MDD. In addition, patients with lower positive emotionality and behavioral activation, as well as higher residual depression (including emotional, cognitive, and social facets), showed decreased probability of remission (≥6 continuous weeks of minimal or absent symptoms) after acute-Phase CT. Finally, patients with greater residual depression, as well as younger age and earlier MDD onset, showed decreased probability of recovery (≥35 continuous weeks of minimal or absent symptoms) after acute-Phase CT. Moderator analyses did not reveal differential prediction across the Continuation Phase treatment arms. These results may help clinicians gauge the prognoses and need for Continuation treatment among MDD patients who respond to acute-Phase CT.
Douglas Kondziolka - One of the best experts on this subject based on the ideXlab platform.
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a randomized sham controlled trial of deep brain stimulation of the ventral capsule ventral striatum for chronic treatment resistant depression
Biological Psychiatry, 2015Co-Authors: Darin D Dougherty, Ali R Rezai, Linda L Carpenter, Robert H Howland, Mahendra T Bhati, John P Oreardon, Emad N Eskandar, Gordon H Baltuch, Andre Machado, Douglas KondziolkaAbstract:Abstract Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label Continuation Phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery–Asberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery–Asberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled Phase of the trial. The response rates at 12, 18, and 24 months during the open-label Continuation Phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled Phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label Continuation Phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
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A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression
Biological psychiatry, 2014Co-Authors: Darin D Dougherty, Ali R Rezai, Linda L Carpenter, Robert H Howland, Mahendra T Bhati, Emad N Eskandar, Gordon H Baltuch, Andre Machado, John P. O’reardon, Douglas KondziolkaAbstract:Abstract Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label Continuation Phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery–Asberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery–Asberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled Phase of the trial. The response rates at 12, 18, and 24 months during the open-label Continuation Phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled Phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label Continuation Phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
Robin B. Jarrett - One of the best experts on this subject based on the ideXlab platform.
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is sleep disturbance linked to short and long term outcomes following treatments for recurrent depression
Journal of Affective Disorders, 2020Co-Authors: Elaine M Boland, Michael E Thase, Jeffrey R. Vittengl, Lee Anna Clark, Robin B. JarrettAbstract:Abstract Background Pre-treatment sleep disturbance has been shown to predict antidepressant treatment outcomes. How changes in sleep disturbance during acute treatment affect longitudinal outcomes, or whether Continuation-Phase treatment further improves sleep disturbance, is unclear. Methods We assessed sleep disturbance repeatedly in: a) 523 adults with recurrent MDD who consented to 12–14 weeks of acute-Phase cognitive therapy (A-CT) and b) 241 A-CT responders at elevated risk for depression relapse/recurrence who were randomized to 8 months of Continuation-Phase treatment (C CT vs. fluoxetine vs. matched pill placebo) and followed protocol-treatment-free for 24 months. Trajectories of change in sleep and depression during and after A-CT were evaluated with multilevel models; individual intercepts and slopes were retained and input into Cox regression models to predict remission, recovery, relapse, and recurrence of MDD. Results Sleep disturbance improved over the course of A-CT, but most patients continued to report clinically significant sleep complaints. Response and remission were more likely in patients with less overall sleep disturbance and those with greater reduction in sleep disturbance during A-CT; these patients also achieved post-A-CT remission and recovery sooner. Sleep improvements endured throughout follow-up but were not enhanced by Continuation-Phase treatment. Sleep disturbance did not predict relapse or recurrence consistently. Limitations Objective sleep disturbance was not assessed. Analyses were not specifically powered to use sleep changes to predict outcomes. Conclusions Improvements in sleep disturbance during A-CT are linked to shorter times to remission and recovery, supporting consideration of monitoring and targeting sleep disturbance in adults with depression.
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initial steps to inform selection of Continuation cognitive therapy or fluoxetine for higher risk responders to cognitive therapy for recurrent major depressive disorder
Psychiatry Research-neuroimaging, 2017Co-Authors: Jeffrey R. Vittengl, Michael E Thase, Lee Anna Clark, Robin B. JarrettAbstract:Abstract Responders to acute-Phase cognitive therapy (A-CT) for major depressive disorder (MDD) often relapse or recur, but Continuation-Phase cognitive therapy (C-CT) or fluoxetine reduces risks for some patients. We tested composite moderators of C-CT versus fluoxetine's preventive effects to inform Continuation treatment selection. Responders to A-CT for MDD judged to be at higher risk for relapse due to unstable or partial remission ( N =172) were randomized to 8 months of C-CT or fluoxetine with clinical management and assessed, free from protocol treatment, for 24 additional months. Pre-Continuation-treatment characteristics that in survival analyses moderated treatments' effects on relapse over 8 months of Continuation-Phase treatment (residual symptoms and negative temperament) and on relapse/recurrence over the full observation period's 32 months (residual symptoms and age) were combined to estimate the potential advantage of C-CT versus fluoxetine for individual patients. Assigning patients to optimal Continuation treatment (i.e., to C-CT or fluoxetine, depending on patients' pre-Continuation-treatment characteristics) resulted in absolute reduction of relapse or recurrence risk by 16–21% compared to the other non-optimal treatment. Although these novel results require replication before clinical application, selecting optimal Continuation treatment (i.e., personalizing treatment) for higher risk A-CT responders may decrease risks of MDD relapse and recurrence substantively.
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Predictors of Longitudinal Outcomes after Unstable Response to Acute Phase Cognitive Therapy for Major Depressive Disorder
Psychotherapy (Chicago Ill.), 2015Co-Authors: Jeffrey R. Vittengl, Michael E Thase, Lee Anna Clark, Robin B. JarrettAbstract:After patients with major depressive disorder (MDD) respond to acute-Phase cognitive therapy (CT), Continuation-Phase treatments may be applied to improve long-term outcomes. We clarified which CT responders experience remission, recovery, relapse, and recurrence by testing baseline demographic, clinical, and personality variables. The sample of CT responders at higher risk of relapse (N = 241) was randomized to 8 months of Continuation-Phase CT, double-blinded fluoxetine, or pill placebo, and followed 24 months (Jarrett & Thase, 2010). Patients with lower positive emotionality and behavioral activation at the end of acute-Phase CT showed increased risk for relapse/recurrence of MDD. In addition, patients with lower positive emotionality and behavioral activation, as well as higher residual depression (including emotional, cognitive, and social facets), showed decreased probability of remission (≥6 continuous weeks of minimal or absent symptoms) after acute-Phase CT. Finally, patients with greater residual depression, as well as younger age and earlier MDD onset, showed decreased probability of recovery (≥35 continuous weeks of minimal or absent symptoms) after acute-Phase CT. Moderator analyses did not reveal differential prediction across the Continuation Phase treatment arms. These results may help clinicians gauge the prognoses and need for Continuation treatment among MDD patients who respond to acute-Phase CT.
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Preventing Depressive Relapse and Recurrence in Higher Risk Cognitive Therapy Responders: A Randomized Trial of Continuation Phase Cognitive Therapy, Fluoxetine, or Matched Pill Placebo
JAMA psychiatry, 2013Co-Authors: Robin B. Jarrett, Edward S Friedman, Abu Minhajuddin, Howard K. Gershenfeld, Michael E ThaseAbstract:Importance Strategies to improve the course of recurrent major depressive disorder have great public health relevance. To reduce the risk of relapse/recurrence after acute Phase cognitive therapy (CT), a Continuation Phase model of therapy may improve outcomes. Objectives To test the efficacy of Continuation Phase CT (C-CT) and fluoxetine for relapse prevention in a pill placebo (PBO)–controlled randomized trial and compare the durability of prophylaxis after disContinuation of treatments. Design A sequential, 3-stage design with an acute Phase (all patients received 12 weeks of CT); 8-month experimental Phase (responders at higher risk were randomized to C-CT, fluoxetine, or PBO); and 24 months of longitudinal, posttreatment follow-up. Setting Two university-based specialty clinics. Patients A total of 523 adults with recurrent major depressive disorder began acute Phase CT, of which 241 higher-risk responders were randomized and 181 subsequently entered the follow-up. Interventions Cognitive therapy responders at higher risk for relapse were randomized to receive 8 months of C-CT (n = 86), fluoxetine (n = 86), or PBO (n = 69). Main Outcomes and Measures Survival analyses of relapse/recurrence rates, as determined by blinded evaluators using DSM-IV criteria and the Longitudinal Interval Follow-up Evaluation. Results As predicted, the C-CT or fluoxetine groups were significantly less likely to relapse than the PBO group across 8 months. Relapse/recurrence rates for C-CT and fluoxetine were nearly identical during the 8 months of treatment, although C-CT patients were more likely to accept randomization, stayed in treatment longer, and attended more sessions than those in the fluoxetine and PBO groups. Contrary to prediction, relapse/recurrence rates following the disContinuation of C-CT and fluoxetine did not differ. Conclusions and Relevance Relapse risk was reduced by both C-CT and fluoxetine in an enriched randomization sampling only CT responders. The preventive effects of C-CT were not significantly more durable than those of fluoxetine after treatment was stopped, suggesting that some higher-risk patients may require alternate longer-term interventions. Trial Registration clinicaltrials.gov Identifiers:NCT00118404,NCT00183664, andNCT00218764
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comparative efficacy and durability of Continuation Phase cognitive therapy for preventing recurrent depression design of a double blinded fluoxetine and pill placebo controlled randomized trial with 2 year follow up
Contemporary Clinical Trials, 2010Co-Authors: Robin B. Jarrett, Michael E ThaseAbstract:Abstract Background Major Depressive Disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower vs. higher risk for relapse; and 2) the subsequent durability of 8-month Continuation Phase therapies in randomized higher risk responders followed for an additional 24 months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to Continuation Phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12–14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression ≤ 12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of Continuation Phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the Continuation Phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete ( n = 523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and Continuation Phase treatments in the largest known sample of CT responders collected worldwide.
Darin D Dougherty - One of the best experts on this subject based on the ideXlab platform.
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a randomized sham controlled trial of deep brain stimulation of the ventral capsule ventral striatum for chronic treatment resistant depression
Biological Psychiatry, 2015Co-Authors: Darin D Dougherty, Ali R Rezai, Linda L Carpenter, Robert H Howland, Mahendra T Bhati, John P Oreardon, Emad N Eskandar, Gordon H Baltuch, Andre Machado, Douglas KondziolkaAbstract:Abstract Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label Continuation Phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery–Asberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery–Asberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled Phase of the trial. The response rates at 12, 18, and 24 months during the open-label Continuation Phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled Phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label Continuation Phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
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A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression
Biological psychiatry, 2014Co-Authors: Darin D Dougherty, Ali R Rezai, Linda L Carpenter, Robert H Howland, Mahendra T Bhati, Emad N Eskandar, Gordon H Baltuch, Andre Machado, John P. O’reardon, Douglas KondziolkaAbstract:Abstract Background Multiple open-label trials of deep brain stimulation (DBS) for treatment-resistant depression (TRD), including those targeting the ventral capsule/ventral striatum target, have shown encouraging response rates. However, no randomized controlled trials of DBS for TRD have been published. Methods Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD. Patients were randomized to active versus sham DBS treatment in a blinded fashion for 16 weeks, followed by an open-label Continuation Phase. The primary outcome measure was response, defined as a 50% or greater improvement on the Montgomery–Asberg Depression Rating Scale from baseline. Results There was no significant difference in response rates between the active (3 of 15 subjects; 20%) and control (2 of 14 subjects; 14.3%) treatment arms and no significant difference between change in Montgomery–Asberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled Phase of the trial. The response rates at 12, 18, and 24 months during the open-label Continuation Phase were 20%, 26.7%, and 23.3%, respectively. Conclusion The results of this first randomized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled Phase. However, a range of 20% to 26.7% of patients did achieve response at any time during the open-label Continuation Phase. Future studies, perhaps utilizing alternative study designs and stimulation parameters, are needed.
Martin B Keller - One of the best experts on this subject based on the ideXlab platform.
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Influence of sex and menopausal status on response, remission, and recurrence in patients with recurrent major depressive disorder treated with venlafaxine extended release or fluoxetine: analysis of data from the PREVENT study.
The Journal of clinical psychiatry, 2013Co-Authors: Susan G Kornstein, Philip T Ninan, Charles B Nemeroff, Madhukar H Trivedi, Michael E Thase, Ronald Pedersen, Peter Holland, Anthony J. Rothschild, Martin B KellerAbstract:OBJECTIVE To evaluate the effects of sex and menopausal status on acute-, Continuation-, and maintenance-Phase treatment outcomes in patients with recurrent major depressive disorder (MDD). METHOD This was a secondary analysis of data from the Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years (PREVENT) trial, a multiPhase, multicenter, double-blind study in which adult outpatients with recurrent MDD (by DSM-IV criteria) were randomly assigned to 10 weeks of acute-Phase venlafaxine extended release (ER) (75-300 mg/d) or fluoxetine (20-60 mg/d). Patients achieving response or remission had 6 months of Continuation-Phase treatment. Responding or remitting patients in the venlafaxine ER group were randomly assigned to venlafaxine ER or placebo for 2 consecutive 12-month maintenance Phases; fluoxetine-treated patients continued receiving fluoxetine. The outcome measures for this analysis were acute- and Continuation-Phase response and remission rates (as measured by the 17-item Hamilton Depression Rating Scale) and time to depression recurrence in the maintenance Phases according to sex and menopausal status at baseline. RESULTS The intent-to-treat population comprised 781 patients in the venlafaxine ER group (65% women) and 266 patients in the fluoxetine group (61% women); 64% of all women were premenopausal, and 25% were postmenopausal (5% perimenopausal; not analyzed). At acute-Phase end, remission rates in the venlafaxine ER vs fluoxetine groups were 44% vs 47% in men, 51% vs 52% in women, 50% vs 52% in premenopausal women, and 52% vs 55% in postmenopausal women. At Continuation-Phase end, remission rates in the venlafaxine ER vs fluoxetine groups were 71% vs 74% in men, 72% vs 67% in women, 72% vs 69% in premenopausal women and 71% vs 63% in postmenopausal women. Response rates were consistent with these findings. Based on a Cox proportional hazards model, sex was not a significant predictor of recurrence during the first or second maintenance Phase (hazard ratio [HR] = 1.233; P = .3712 and HR = 1.103; P = .8075, respectively), and neither was menopausal status at acute-Phase baseline (HR = 0.941; P = .8234 and HR = 0.531; P = .2065, respectively). CONCLUSIONS In this study of patients with recurrent MDD, treatment outcomes with venlafaxine ER and fluoxetine did not differ on the basis of sex or menopausal status. Our confidence in these findings is limited by the lack of a placebo arm during the acute and Continuation Phases and by the small sample sizes for subgroup analyses in the maintenance Phases. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00046020.
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the prevention of recurrent episodes of depression with venlafaxine for two years prevent study outcomes from the acute and Continuation Phases
Biological Psychiatry, 2007Co-Authors: Martin B Keller, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, James H Kocsis, Susan G Kornstein, Richard C Shelton, Madhukar H Trivedi, Michael E Thase, David L DunnerAbstract:Background We evaluated the comparative efficacy and safety of venlafaxine extended release (ER) and fluoxetine in the acute and Continuation Phases of treatment. Methods In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive venlafaxine ER (75–300 mg/day; n = 821) or fluoxetine (20–60 mg/day; n = 275). After a 10-week acute treatment Phase, responders entered a 6-month Continuation Phase of ongoing therapy with double-blind venlafaxine ER ( n = 530) or fluoxetine ( n = 185). In the acute Phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score ≤12 or ≥50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score ≤7. In the Continuation Phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. Results At the acute treatment Phase end point, response rates were 79% for both venlafaxine ER and fluoxetine; remission rates were 49% and 50% for venlafaxine ER and fluoxetine, respectively. In the Continuation Phase, response rates were 90% and 92%, and remission rates were 72% and 69% for venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the Continuation Phase were 52% and 58% for venlafaxine ER and fluoxetine, respectively. Conclusion Venlafaxine ER and fluoxetine were comparably effective during both acute and Continuation Phase therapy.
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The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance Phases.
The Journal of Clinical Psychiatry, 2007Co-Authors: Martin B Keller, Charles B Nemeroff, Edward S Friedman, Alan J Gelenberg, James H Kocsis, Susan G Kornstein, Richard C Shelton, Madhukar H Trivedi, Michael E Thase, David L DunnerAbstract:OBJECTIVE: To report second-year results from the 2-year maintenance Phase of a long-term study to evaluate the efficacy and safety of venlafaxine extended release (ER) in preventing recurrence of depression. METHOD: Outpatients with recurrent unipolar depression (DSM-IV criteria; N = 1096) were randomly assigned in a 3:1 ratio to 10 weeks of treatment with venlafaxine ER or fluoxetine. Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score or= 50% decrease from baseline) entered a 6-month, double-blind Continuation Phase on the same medication. Continuation-Phase responders were enrolled into maintenance treatment consisting of 2 consecutive 12-month Phases. At the start of each maintenance Phase, venlafaxine ER responders were randomly assigned to receive double-blind treatment with venlafaxine ER or placebo, and fluoxetine responders were continued for each period. The second 12-month maintenance Phase compared the time to recurrence of depression with venlafaxine ER (75 to 300 mg/day) versus placebo as the primary efficacy measure. The primary definition of recurrence was a HAM-D(17) total score > 12 and < 50% reduction from baseline (acute Phase) at 2 consecutive visits or at the last valid visit prior to disContinuation. The time to recurrence was evaluated using Kaplan-Meier methods and compared between the venlafaxine ER and placebo groups using log-rank tests. Secondary outcome measures included rates of response and remission (defined as HAM-D(17)
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Efficacy of mirtazapine for prevention of depressive relapse: a placebo-controlled double-blind trial of recently remitted high-risk patients.
The Journal of clinical psychiatry, 2001Co-Authors: Michael E Thase, Martin B Keller, Andrew A. Nierenberg, Panagides JAbstract:Background: The necessity of antidepressant Continuation-Phase therapy following acute-Phase response has resulted in the need to characterize the longer-term efficacy and safety of all new medications. Previous studies using extension protocols suggest that mirtazapine has sustained antidepressant effects. The current study was performed to evaluate the efficacy and safety of up to 1 year of mirtazapine therapy, using a more rigorous, randomized, placebo-controlled disContinuation design. Method: An intent-to-treat sample of 410 patients meeting DSM-IV criteria for moderateto-severe recurrent or chronic major depressive episodes began 8 to 12 weeks of open-label therapy with mirtazapine (flexibly titrated, 15-45 mg/day). Thereafter, 156 fully remitted patients (according to Hamilton Rating Scale for Depression and Clinical Global Impressions-Improvement scores) were randomly assigned to receive 40 weeks of double-blind Continuation-Phase therapy with either mirtazapine or placebo. Results: Mirtazapine therapy reduced the rate of depressive relapse by more than half, with 43.8% of patients relapsing on treatment with placebo as compared with 19.7% of the mirtazapine-treated patients. The disContinuation rate due to adverse events was 11.8% for active mirtazapine therapy versus 2.5% for placebo. Although weight gain was significantly greater in the group receiving active medication during the double-blind Phase (p = .001), patients taking mirtazapine gained only 1.4 kg (3.1 lb) across the 40 weeks of Continuation therapy, and there was no difference in the rates of weight gain as a newonset adverse event. Conclusion: Continuation-Phase therapy with mirtazapine is effective and well tolerated.