Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression
Overview
- Phase
- Phase 3
- Intervention
- Olanzapine
- Conditions
- Major Depressive Disorder With Psychotic Features
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 259
- Locations
- 4
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Major depressive disorder, single or recurrent, with psychotic features
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
- •Intolerance to SSRIs or olanzapine
Arms & Interventions
olanzapine/sertraline combination
sertraline plus olanzapine
Intervention: Olanzapine
olanzapine/sertraline combination
sertraline plus olanzapine
Intervention: Sertraline
olanzapine plus placebo
olanzapine (5 - 20mg/day) plus placebo
Intervention: Olanzapine
olanzapine plus placebo
olanzapine (5 - 20mg/day) plus placebo
Intervention: placebo
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- Scores on CGI-S Compared to Baseline Over the Course of the Trial(Weeks 1 to 12)