Study of Pharmacotherapy of Psychotic Depression

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

Detailed Description
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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.

Official Title
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Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression

Conditions
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Major Depressive Disorder With Psychotic Features

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Sertraline
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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 Pregnant Intolerance to SSRIs or olanzapine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: olanzapine/sertraline combination<br>sertraline plus olanzapine | Drug: Olanzapine<br>* 10-20mg/day<br>* Other names: Zyprexa;Drug: Sertraline<br>* 150-200mg/day<br>* Other names: Zoloft;|
| Placebo Comparator: olanzapine plus placebo<br>olanzapine (5 - 20mg/day) plus placebo | Drug: Olanzapine<br>* 10-20mg/day<br>* Other names: Zyprexa;Other: placebo<br>* tablet that ressembles sertraline but contains no medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Weeks 1 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on CGI-S Compared to Baseline Over the Course of the Trial | 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. | Weeks 1 to 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder with psychotic features, SSRI, Delusional Depression, Randomized Trial, Combination Treatment, Atypical Antipsychotic