A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: The Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

Barnett S. Meyers, Alastair J. Flint, Anthony J. Rothschild, Benoit H. Mulsant, Ellen M. Whyte, Catherine Peasley-Miklus, Eros Papademetriou, Andrew C. Leon, Moonseong Heo

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Abstract

Context: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. Objectives: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age. Design: Twelve-week, double-blind, randomized, controlled trial. Setting: Clinical services of 4 academic sites. Patients: Two hundred fifty-nine subjects with MD with psychotic features randomized by age (<60 or ≥60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in 117 younger adults vs 71.7 [7.8] years in 142 geriatric participants). Intervention: Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day. Main Outcome Measure: Remission rates of MD with psychotic features. Results: Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.12-1.47; P < .001); 41.9% of subjects who underwent combination therapy were in remission at their last assessment compared with 23.9% of subjects treated with monotherapy (χ12 = 9.53, P = .002). Combination therapy was comparably superior in both younger (OR, 1.25; 95% CI, 1.05-1.50; P = .02) and older (OR, 1.34; 95% CI, 1.09-1.66; P = .01) adults. Overall, tolerability was comparable across age groups. Both age groups had significant increases in cholesterol and triglyceride concentrations, but statistically significant increases in glucose occurred only in younger adults. Younger adults gained significantly more weight than older subjects (mean [SD], 6.5 [6.6] kg vs 3.3 [4.9] kg, P = .001). Conclusions: Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks. Trial Registration: clinicaltrials.gov Identifier: NCT00056472.

Original languageEnglish (US)
Pages (from-to)838-847
Number of pages10
JournalArchives of General Psychiatry
Volume66
Issue number8
DOIs
StatePublished - Aug 2009

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olanzapine
Sertraline
Randomized Controlled Trials
Placebos
Antipsychotic Agents
Drug Therapy
Young Adult
Odds Ratio
Confidence Intervals
Geriatrics
Age Groups
Serotonin Uptake Inhibitors
Therapeutics
Triglycerides
Cholesterol
Outcome Assessment (Health Care)
Weights and Measures
Glucose

ASJC Scopus subject areas

  • Psychiatry and Mental health

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A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression : The Study of Pharmacotherapy of Psychotic Depression (STOP-PD). / Meyers, Barnett S.; Flint, Alastair J.; Rothschild, Anthony J.; Mulsant, Benoit H.; Whyte, Ellen M.; Peasley-Miklus, Catherine; Papademetriou, Eros; Leon, Andrew C.; Heo, Moonseong.

In: Archives of General Psychiatry, Vol. 66, No. 8, 08.2009, p. 838-847.

Research output: Contribution to journalArticle

Meyers, Barnett S. ; Flint, Alastair J. ; Rothschild, Anthony J. ; Mulsant, Benoit H. ; Whyte, Ellen M. ; Peasley-Miklus, Catherine ; Papademetriou, Eros ; Leon, Andrew C. ; Heo, Moonseong. / A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression : The Study of Pharmacotherapy of Psychotic Depression (STOP-PD). In: Archives of General Psychiatry. 2009 ; Vol. 66, No. 8. pp. 838-847.
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abstract = "Context: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. Objectives: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age. Design: Twelve-week, double-blind, randomized, controlled trial. Setting: Clinical services of 4 academic sites. Patients: Two hundred fifty-nine subjects with MD with psychotic features randomized by age (<60 or ≥60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in 117 younger adults vs 71.7 [7.8] years in 142 geriatric participants). Intervention: Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day. Main Outcome Measure: Remission rates of MD with psychotic features. Results: Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo (odds ratio [OR], 1.28; 95{\%} confidence interval [CI], 1.12-1.47; P < .001); 41.9{\%} of subjects who underwent combination therapy were in remission at their last assessment compared with 23.9{\%} of subjects treated with monotherapy (χ12 = 9.53, P = .002). Combination therapy was comparably superior in both younger (OR, 1.25; 95{\%} CI, 1.05-1.50; P = .02) and older (OR, 1.34; 95{\%} CI, 1.09-1.66; P = .01) adults. Overall, tolerability was comparable across age groups. Both age groups had significant increases in cholesterol and triglyceride concentrations, but statistically significant increases in glucose occurred only in younger adults. Younger adults gained significantly more weight than older subjects (mean [SD], 6.5 [6.6] kg vs 3.3 [4.9] kg, P = .001). Conclusions: Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks. Trial Registration: clinicaltrials.gov Identifier: NCT00056472.",
author = "Meyers, {Barnett S.} and Flint, {Alastair J.} and Rothschild, {Anthony J.} and Mulsant, {Benoit H.} and Whyte, {Ellen M.} and Catherine Peasley-Miklus and Eros Papademetriou and Leon, {Andrew C.} and Moonseong Heo",
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T2 - The Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

AU - Meyers, Barnett S.

AU - Flint, Alastair J.

AU - Rothschild, Anthony J.

AU - Mulsant, Benoit H.

AU - Whyte, Ellen M.

AU - Peasley-Miklus, Catherine

AU - Papademetriou, Eros

AU - Leon, Andrew C.

AU - Heo, Moonseong

PY - 2009/8

Y1 - 2009/8

N2 - Context: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. Objectives: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age. Design: Twelve-week, double-blind, randomized, controlled trial. Setting: Clinical services of 4 academic sites. Patients: Two hundred fifty-nine subjects with MD with psychotic features randomized by age (<60 or ≥60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in 117 younger adults vs 71.7 [7.8] years in 142 geriatric participants). Intervention: Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day. Main Outcome Measure: Remission rates of MD with psychotic features. Results: Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.12-1.47; P < .001); 41.9% of subjects who underwent combination therapy were in remission at their last assessment compared with 23.9% of subjects treated with monotherapy (χ12 = 9.53, P = .002). Combination therapy was comparably superior in both younger (OR, 1.25; 95% CI, 1.05-1.50; P = .02) and older (OR, 1.34; 95% CI, 1.09-1.66; P = .01) adults. Overall, tolerability was comparable across age groups. Both age groups had significant increases in cholesterol and triglyceride concentrations, but statistically significant increases in glucose occurred only in younger adults. Younger adults gained significantly more weight than older subjects (mean [SD], 6.5 [6.6] kg vs 3.3 [4.9] kg, P = .001). Conclusions: Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks. Trial Registration: clinicaltrials.gov Identifier: NCT00056472.

AB - Context: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. Objectives: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age. Design: Twelve-week, double-blind, randomized, controlled trial. Setting: Clinical services of 4 academic sites. Patients: Two hundred fifty-nine subjects with MD with psychotic features randomized by age (<60 or ≥60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in 117 younger adults vs 71.7 [7.8] years in 142 geriatric participants). Intervention: Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day. Main Outcome Measure: Remission rates of MD with psychotic features. Results: Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.12-1.47; P < .001); 41.9% of subjects who underwent combination therapy were in remission at their last assessment compared with 23.9% of subjects treated with monotherapy (χ12 = 9.53, P = .002). Combination therapy was comparably superior in both younger (OR, 1.25; 95% CI, 1.05-1.50; P = .02) and older (OR, 1.34; 95% CI, 1.09-1.66; P = .01) adults. Overall, tolerability was comparable across age groups. Both age groups had significant increases in cholesterol and triglyceride concentrations, but statistically significant increases in glucose occurred only in younger adults. Younger adults gained significantly more weight than older subjects (mean [SD], 6.5 [6.6] kg vs 3.3 [4.9] kg, P = .001). Conclusions: Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks. Trial Registration: clinicaltrials.gov Identifier: NCT00056472.

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