Phase 3 N=259 Randomized Quadruple-blind Treatment

Study of Pharmacotherapy of Psychotic Depression

Major Depressive Disorder With Psychotic Features

Bottom Line

View on ClinicalTrials.gov: NCT00056472 ↗

Enrolled (actual)

259

Serious AEs

4.6%

Results posted

Aug 2013

Primary outcome: 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 participants — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Olanzapine (Drug); Sertraline (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Jun 2008

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

Summary

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

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

View full record on ClinicalTrials.gov →

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.