Treatment of Major Depressive Disorder With Psychotic Features.

Major Depression With Psychotic Features Clinical Trial

Official title: Treatment of Major Depressive Disorder With Psychotic Features With Risperidone Monotherapy; Risperidone and Sertraline; or Haloperidol and Sertraline

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of risperidone monotherapy in the treatment of psychotic depression. We hypothesize that risperidone is as equally as effective as haloperidol plus sertraline for depression with psychotic features

Clinical Trial Description

Risperidone is a novel antipsychotic that is usually not associated with the adverse effects of neuroleptics. In addition, preliminary evidence suggests that it has additional mood stabilizing properties as compared with neuroleptics. We are examining the effect of risperidone alone for the treatment of psychotic depression. After providing written informed consent, subjects with major depression and psychosis will undergo a routine medical and neurological evaluation. If subjects qualify they will undergo a 3 to 7 day washout. Subjects will be randomly assigned under double-blind conditions to risperidone plus placebo; risperidone plus sertraline; or haloperidol (HPDL) plus sertraline in a prospective parallel design for a 6 week trial. Outcome measures include the Hamilton Rating Depression Scale, The Positive and Negative Symptom Scale and the Clinician Administered Ratings Scale for Mania and Simpson Angus Scale. Rating will be conducted on a weekly basis throughout the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression With Psychotic Features
• Mental Disorders
• Psychotic Disorders

• NCT number: NCT00174590
• Study type: Interventional
• Source: Rush University Medical Center
• Status: Terminated
• Phase: Phase 3
• Start date: September 2001
• Completion date: August 2007