Phase 3
Completed N=259
Study of Pharmacotherapy of Psychotic Depression
Major Depressive Disorder With Psychotic Features
Source: ClinicalTrials.gov NCT00056472 ↗
Enrolled (actual)
259
Serious AEs
4.6%
Results posted
Aug 2013
Primary outcomePrimary: 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 — 54; 31 participants — p=<.001
Summary
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
54; 31 | <.001 sig |
| SECONDARY Scores on CGI-S Compared to Baseline Over the Course of the Trial |
2.24; 2.48 | .02 sig |
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
- Pregnant
- Intolerance to SSRIs or olanzapine
Data sourced from ClinicalTrials.gov (NCT00056472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.