Status:
TERMINATED
Treatment of Major Depressive Disorder With Psychotic Features.
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Janssen, LP
Conditions:
Major Depression With Psychotic Features
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 hal...
Detailed 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 propert...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00174590
Start Date
September 1 2001
End Date
August 1 2007
Last Update
January 10 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rush University Medical Center
Chicago, Illinois, United States, 60612