drugset / Trial / NCT00094926
A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.
Phase 3
Completed
275 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in the past year.
Timeline
- Start
- 2004-05
- Primary completion
- —
- Completion
- 2007-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 25 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 37.5 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 50 mg | Intramuscular |