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Michael E Thase - One of the best experts on this subject based on the ideXlab platform.
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olanzapine Fluoxetine combination in patients with treatment resistant depression rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
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Olanzapine/Fluoxetine combination in patients with treatment-resistant depression: rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies.
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
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A randomized, double-blind comparison of olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in treatment-resistant major depressive disorder.
The Journal of clinical psychiatry, 2007Co-Authors: Michael E Thase, Michael Case, S. Corya, Olawale O. Osuntokun, David Henley, Todd M. Sanger, Susan B. Watson, Sanjay DubéAbstract:OBJECTIVE Two parallel, 8-week double-blind studies compared olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in outpatients with treatment-resistant depression (TRD). METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospective failure on Fluoxetine. Following an 8-week Fluoxetine lead-in, 605 nonresponders with DSM-IV major depressive disorder were randomly assigned to olanzapine/Fluoxetine combination, olanzapine, or Fluoxetine. The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted from April 2002 to May 2005. RESULTS After 8 weeks of double-blind treatment, Study 1 revealed no statistically significant therapy differences in MADRS mean change (olanzapine/Fluoxetine combination: -11.0, Fluoxetine: -9.4, olanzapine: -10.5). In Study 2, olanzapine/Fluoxetine combination demonstrated significantly greater MADRS improvement (-14.5) than Fluoxetine (-8.6, p < .001) and olanzapine (-7.0, p < .001). Pooled study results revealed significant differences for olanzapine/ Fluoxetine combination (-12.7) versus Fluoxetine (-9.0, p < .001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for olanzapine/ Fluoxetine combination, 17% for Fluoxetine, and 15% for olanzapine. Adverse events were consistent with previous studies. Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ Fluoxetine combination, +0.8 for Fluoxetine, and +2.7 for olanzapine. Mean weight change (kg) was +4.9 for olanzapine/Fluoxetine combination, +0.4 for Fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL) was +11.4 for olanzapine/Fluoxetine combination, +4.9 for Fluoxetine, and +9.9 for olanzapine. CONCLUSION Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/Fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or Fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/Fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT00035321.
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a randomized double blind comparison of olanzapine Fluoxetine combination olanzapine and Fluoxetine in treatment resistant major depressive disorder
The Journal of Clinical Psychiatry, 2007Co-Authors: Michael E Thase, Michael Case, S. Corya, Olawale O. Osuntokun, David Henley, Todd M. Sanger, Susan B. Watson, Sanjay DubéAbstract:OBJECTIVE Two parallel, 8-week double-blind studies compared olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in outpatients with treatment-resistant depression (TRD). METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospective failure on Fluoxetine. Following an 8-week Fluoxetine lead-in, 605 nonresponders with DSM-IV major depressive disorder were randomly assigned to olanzapine/Fluoxetine combination, olanzapine, or Fluoxetine. The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted from April 2002 to May 2005. RESULTS After 8 weeks of double-blind treatment, Study 1 revealed no statistically significant therapy differences in MADRS mean change (olanzapine/Fluoxetine combination: -11.0, Fluoxetine: -9.4, olanzapine: -10.5). In Study 2, olanzapine/Fluoxetine combination demonstrated significantly greater MADRS improvement (-14.5) than Fluoxetine (-8.6, p < .001) and olanzapine (-7.0, p < .001). Pooled study results revealed significant differences for olanzapine/ Fluoxetine combination (-12.7) versus Fluoxetine (-9.0, p < .001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for olanzapine/ Fluoxetine combination, 17% for Fluoxetine, and 15% for olanzapine. Adverse events were consistent with previous studies. Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ Fluoxetine combination, +0.8 for Fluoxetine, and +2.7 for olanzapine. Mean weight change (kg) was +4.9 for olanzapine/Fluoxetine combination, +0.4 for Fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL) was +11.4 for olanzapine/Fluoxetine combination, +4.9 for Fluoxetine, and +9.9 for olanzapine. CONCLUSION Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/Fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or Fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/Fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT00035321.
Michael Case - One of the best experts on this subject based on the ideXlab platform.
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olanzapine Fluoxetine combination in patients with treatment resistant depression rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
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Olanzapine/Fluoxetine combination in patients with treatment-resistant depression: rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies.
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
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A randomized, double-blind comparison of olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in treatment-resistant major depressive disorder.
The Journal of clinical psychiatry, 2007Co-Authors: Michael E Thase, Michael Case, S. Corya, Olawale O. Osuntokun, David Henley, Todd M. Sanger, Susan B. Watson, Sanjay DubéAbstract:OBJECTIVE Two parallel, 8-week double-blind studies compared olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in outpatients with treatment-resistant depression (TRD). METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospective failure on Fluoxetine. Following an 8-week Fluoxetine lead-in, 605 nonresponders with DSM-IV major depressive disorder were randomly assigned to olanzapine/Fluoxetine combination, olanzapine, or Fluoxetine. The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted from April 2002 to May 2005. RESULTS After 8 weeks of double-blind treatment, Study 1 revealed no statistically significant therapy differences in MADRS mean change (olanzapine/Fluoxetine combination: -11.0, Fluoxetine: -9.4, olanzapine: -10.5). In Study 2, olanzapine/Fluoxetine combination demonstrated significantly greater MADRS improvement (-14.5) than Fluoxetine (-8.6, p < .001) and olanzapine (-7.0, p < .001). Pooled study results revealed significant differences for olanzapine/ Fluoxetine combination (-12.7) versus Fluoxetine (-9.0, p < .001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for olanzapine/ Fluoxetine combination, 17% for Fluoxetine, and 15% for olanzapine. Adverse events were consistent with previous studies. Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ Fluoxetine combination, +0.8 for Fluoxetine, and +2.7 for olanzapine. Mean weight change (kg) was +4.9 for olanzapine/Fluoxetine combination, +0.4 for Fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL) was +11.4 for olanzapine/Fluoxetine combination, +4.9 for Fluoxetine, and +9.9 for olanzapine. CONCLUSION Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/Fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or Fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/Fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT00035321.
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a randomized double blind comparison of olanzapine Fluoxetine combination olanzapine and Fluoxetine in treatment resistant major depressive disorder
The Journal of Clinical Psychiatry, 2007Co-Authors: Michael E Thase, Michael Case, S. Corya, Olawale O. Osuntokun, David Henley, Todd M. Sanger, Susan B. Watson, Sanjay DubéAbstract:OBJECTIVE Two parallel, 8-week double-blind studies compared olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in outpatients with treatment-resistant depression (TRD). METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospective failure on Fluoxetine. Following an 8-week Fluoxetine lead-in, 605 nonresponders with DSM-IV major depressive disorder were randomly assigned to olanzapine/Fluoxetine combination, olanzapine, or Fluoxetine. The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted from April 2002 to May 2005. RESULTS After 8 weeks of double-blind treatment, Study 1 revealed no statistically significant therapy differences in MADRS mean change (olanzapine/Fluoxetine combination: -11.0, Fluoxetine: -9.4, olanzapine: -10.5). In Study 2, olanzapine/Fluoxetine combination demonstrated significantly greater MADRS improvement (-14.5) than Fluoxetine (-8.6, p < .001) and olanzapine (-7.0, p < .001). Pooled study results revealed significant differences for olanzapine/ Fluoxetine combination (-12.7) versus Fluoxetine (-9.0, p < .001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for olanzapine/ Fluoxetine combination, 17% for Fluoxetine, and 15% for olanzapine. Adverse events were consistent with previous studies. Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ Fluoxetine combination, +0.8 for Fluoxetine, and +2.7 for olanzapine. Mean weight change (kg) was +4.9 for olanzapine/Fluoxetine combination, +0.4 for Fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL) was +11.4 for olanzapine/Fluoxetine combination, +4.9 for Fluoxetine, and +9.9 for olanzapine. CONCLUSION Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/Fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or Fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/Fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT00035321.
Todd M Durell - One of the best experts on this subject based on the ideXlab platform.
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olanzapine Fluoxetine combination in patients with treatment resistant depression rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
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Olanzapine/Fluoxetine combination in patients with treatment-resistant depression: rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies.
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
Sanjay Dubé - One of the best experts on this subject based on the ideXlab platform.
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A randomized, double-blind comparison of olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in treatment-resistant major depressive disorder.
The Journal of clinical psychiatry, 2007Co-Authors: Michael E Thase, Michael Case, S. Corya, Olawale O. Osuntokun, David Henley, Todd M. Sanger, Susan B. Watson, Sanjay DubéAbstract:OBJECTIVE Two parallel, 8-week double-blind studies compared olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in outpatients with treatment-resistant depression (TRD). METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospective failure on Fluoxetine. Following an 8-week Fluoxetine lead-in, 605 nonresponders with DSM-IV major depressive disorder were randomly assigned to olanzapine/Fluoxetine combination, olanzapine, or Fluoxetine. The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted from April 2002 to May 2005. RESULTS After 8 weeks of double-blind treatment, Study 1 revealed no statistically significant therapy differences in MADRS mean change (olanzapine/Fluoxetine combination: -11.0, Fluoxetine: -9.4, olanzapine: -10.5). In Study 2, olanzapine/Fluoxetine combination demonstrated significantly greater MADRS improvement (-14.5) than Fluoxetine (-8.6, p < .001) and olanzapine (-7.0, p < .001). Pooled study results revealed significant differences for olanzapine/ Fluoxetine combination (-12.7) versus Fluoxetine (-9.0, p < .001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for olanzapine/ Fluoxetine combination, 17% for Fluoxetine, and 15% for olanzapine. Adverse events were consistent with previous studies. Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ Fluoxetine combination, +0.8 for Fluoxetine, and +2.7 for olanzapine. Mean weight change (kg) was +4.9 for olanzapine/Fluoxetine combination, +0.4 for Fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL) was +11.4 for olanzapine/Fluoxetine combination, +4.9 for Fluoxetine, and +9.9 for olanzapine. CONCLUSION Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/Fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or Fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/Fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT00035321.
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a randomized double blind comparison of olanzapine Fluoxetine combination olanzapine and Fluoxetine in treatment resistant major depressive disorder
The Journal of Clinical Psychiatry, 2007Co-Authors: Michael E Thase, Michael Case, S. Corya, Olawale O. Osuntokun, David Henley, Todd M. Sanger, Susan B. Watson, Sanjay DubéAbstract:OBJECTIVE Two parallel, 8-week double-blind studies compared olanzapine/Fluoxetine combination, olanzapine, and Fluoxetine in outpatients with treatment-resistant depression (TRD). METHOD Treatment-resistant depression was defined as a documented history of current-episode antidepressant failure plus a prospective failure on Fluoxetine. Following an 8-week Fluoxetine lead-in, 605 nonresponders with DSM-IV major depressive disorder were randomly assigned to olanzapine/Fluoxetine combination, olanzapine, or Fluoxetine. The primary outcome measure was baseline-to-endpoint mean change on the Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted from April 2002 to May 2005. RESULTS After 8 weeks of double-blind treatment, Study 1 revealed no statistically significant therapy differences in MADRS mean change (olanzapine/Fluoxetine combination: -11.0, Fluoxetine: -9.4, olanzapine: -10.5). In Study 2, olanzapine/Fluoxetine combination demonstrated significantly greater MADRS improvement (-14.5) than Fluoxetine (-8.6, p < .001) and olanzapine (-7.0, p < .001). Pooled study results revealed significant differences for olanzapine/ Fluoxetine combination (-12.7) versus Fluoxetine (-9.0, p < .001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for olanzapine/ Fluoxetine combination, 17% for Fluoxetine, and 15% for olanzapine. Adverse events were consistent with previous studies. Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ Fluoxetine combination, +0.8 for Fluoxetine, and +2.7 for olanzapine. Mean weight change (kg) was +4.9 for olanzapine/Fluoxetine combination, +0.4 for Fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL) was +11.4 for olanzapine/Fluoxetine combination, +4.9 for Fluoxetine, and +9.9 for olanzapine. CONCLUSION Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/Fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or Fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/Fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov identifier: NCT00035321.
Mauricio Tohen - One of the best experts on this subject based on the ideXlab platform.
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olanzapine Fluoxetine combination in patients with treatment resistant depression rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.
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Olanzapine/Fluoxetine combination in patients with treatment-resistant depression: rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies.
The Journal of Clinical Psychiatry, 2010Co-Authors: Mauricio Tohen, Scott J Burke, Michael Case, Madhukar H Trivedi, Michael E Thase, Todd M DurellAbstract:OBJECTIVE: To characterize response profiles of olanzapine/Fluoxetine combination therapy in treatment-resistant depression (TRD) and to investigate predictive relationships of early improvement with olanzapine/Fluoxetine combination for subsequent response/remission during the acute phase of treatment. METHOD: Results were pooled from 5 outpatient studies comparing oral olanzapine/Fluoxetine combination, Fluoxetine, or olanzapine for a maximum of 8 weeks in patients with TRD who had at least 1 historical antidepressant treatment failure during the current episode and who failed a prospective antidepressant therapy during the study lead-in period. Mean Montgomery-Asberg Depression Rating Scale (MADRS) total and core mood items scores from the 8-week evaluation period were compared across treatment groups. Positive and negative predictive values (PPVs, NPVs) were computed from olanzapine/Fluoxetine combination-treated patients demonstrating response and remission based on whether they demonstrated early improvement. RESULTS: Mean olanzapine/Fluoxetine combination MADRS score reductions were significantly greater than Fluoxetine by week 0.5 and olanzapine by week 1. Significantly more olanzapine/Fluoxetine combination patients demonstrated MADRS onset of response compared with Fluoxetine and olanzapine patients (P < .001 for both MADRS total and core mood items). In olanzapine/Fluoxetine combination patients, 38.1% exhibited MADRS total score response versus 26.9% of Fluoxetine patients (P < .001) and 22.2% of olanzapine patients (P < .001). NPVs for MADRS total and core mood items response and remission ranged from 85.7% to 92.1%; PPVs ranged from 29.9% to 45.1%. CONCLUSIONS: Olanzapine/Fluoxetine combination is superior to Fluoxetine and olanzapine in producing early improvement in patients with TRD. The absence of early improvement is highly predictive for overall response failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00035321.