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.
Phase:
Phase 4
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
University of Massachusetts, Worcester University of Pittsburgh University of Toronto