At a glance
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Sustaining Remission of Psychotic Depression
In Brief
A Phase 4 clinical trial evaluating Sertraline + Olanzapine and Sertraline + Placebo for Psychotic Depression. Completed, enrolled 269 participants across 4 sites in 2 countries.
Detailed Summary
The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. It is predicted that this combination will improve symptoms of psychotic depression and be associated metabolic side effects. Factors that moderate tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks, followed by a period of 8 weeks during which participants will continue to take the same medications to stabilize the remission from symptoms of psychotic depression. The maintenance phase will be a randomized, double-blind, placebo-controlled study of olanzapine for a period of up to 36 weeks to test whether continuing this combination decreases the risk of relapse and whether discontinuing the combination leads to improvement in metabolic measures. Subjects who complete the acute phase will be asked to consent separately to the randomized maintenance phase.
Study Details
Timeline
Interventions
Olanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening
Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.