Treatment of Major Depressive Disorder With Psychotic Features.

Stopped early · Phase 3

Conditions studied: Major Depression With Psychotic Features

In brief

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

Key facts

Study ID

NCT00174590

Run by

Rush University Medical Center

People needed

30

Starts

2001-09-01

Expected to finish

2007-08-01

Last updated by the study team

2008-01-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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