Psychotic Depression Clinical Trial
Official title:
Sustaining Remission of Psychotic Depression
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.
The original STOP-PD study established that the combination of olanzapine and sertraline was significantly better than olanzapine alone in achieving remission of psychotic depression. This STOP-PD-II Sustaining Remission study aims to assess the long-term tolerability of taking this combination of medications and their efficacy at preventing a relapse of the symptoms. The acute phase of the study will monitor the efficacy and tolerability of the olanzapine and sertraline combination, including investigation of weight and metabolic variables, age effects on treatment response and tolerability, and the association of genetic polymorphisms to response or relapse. When subjects are stabilized on these medications for a period of 8 weeks they will be invited to participate in the randomized phase of the research: the olanzapine will be placebo-controlled, meaning half of the subjects will continue to take the olanzapine/sertraline combination and half will take a sertraline/placebo combination, for a period of 36 weeks. Symptoms and side effects will be monitored regularly throughout this phase. Randomization will be stratified on a 1:1 basis by age 60 and above. ;
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