drugset / Trial / NCT00571688
Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
Phase 4
Completed
50 enrolled
Vanderbilt University
Ortho-McNeil Janssen Scientific Affairs, LLC · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study will evaluate the relative effectiveness of risperidone Consta injections occurring every 2 weeks in contrast to treatment as usual in preventing symptomatic relapse and rates of rehospitalization or admission into respite care for bipolar patients. Hypothesis: Risperdal Consta injections every 2 weeks will reduce the number of symptomatic relapses into mania, hypomania, mixed state, or depression, as shown by key indicators that include symptomatic relapse, rehospitalizations, emergency or urgent care visits, respite care, and intensive outpatient treatment as compared to treatment as usual.
Timeline
- Start
- 2007-11
- Primary completion
- 2009-02
- Completion
- 2009-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 25 mg | Intramuscular |