Study of Pharmacotherapy of Psychotic Depression

Phase 3

Completed

Brief Summary: This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Detailed Description: Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.

This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

History of substance abuse or dependence within the 3 months prior to enrollment
Acute or unstable medical illness
Diagnosis of schizophrenia or other psychotic disorders
Pregnant
Intolerance to SSRIs or olanzapine

Arm && Interventions

Group	Intervention	Description
olanzapine/sertraline combination	Olanzapine	sertraline plus olanzapine
olanzapine plus placebo	Olanzapine	olanzapine (5 - 20mg/day) plus placebo
olanzapine plus placebo	placebo	olanzapine (5 - 20mg/day) plus placebo
olanzapine/sertraline combination	Sertraline	sertraline plus olanzapine

Primary Outcome Measures

Name	Time	Method
Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial	Weeks 1 to 12	Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior.

Secondary Outcome Measures

Name	Time	Method
Scores on CGI-S Compared to Baseline Over the Course of the Trial	Weeks 1 to 12	A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.

Locations (4): University of Massachusetts Medical School
🇺🇸
Worcester, Massachusetts, United States
University of Toronto
🇨🇦
Toronto, Ontario, Canada
Cornell University
🇺🇸
New York, New York, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States