Treatment of Major Depressive Disorder With Psychotic Features.

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Subjects will be men and women 18 to 70 years of age with major depression and psychosis that is either an initial episode or a recurrent episode (unipolar or bipolar).

• Subjects with an anxiety disorder or an additional mood disorder such as dysthymia are eligible.

• Baseline HDRS score of greater than 21.

• A baseline PANSS score of greater than 4 on at least one of the 5 psychosis items

Exclusion Criteria:

• Pregnant women Women of child-bearing age who refuse a urine pregnancy test or who refuse to use a contraceptive technique when sexually active.

• Persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; a current substance dependence disorder; or a dementing disorder are excluded.

• Persons with serious, unstable medical illnesses.