Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Bipolar Disorder
Interventions
DRUG

Risperdal (risperidone) Consta

Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular (IM) gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.

DRUG

Treatment as usual

Treatment was provided in this arm based solely on the choice of the treatment provider and participant. Treatment providers were not part of the study staff and were completely free to make treatment choices except that they were not allowed to select a long-acting injectible.

Trial Locations (1)

37228

Mental Health Cooperative, Inc., Nashville

All Listed Sponsors
collaborator

Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

lead

Vanderbilt University

OTHER

NCT00571688 - Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder? | Biotech Hunter | Biotech Hunter