Clinical trial
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention…
NCT00132678 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed
Key facts
| NCT number | NCT00132678 |
|---|---|
| Title | A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes |
| Official title | A Randomized, Double-blind, Placebo-controlled Study to Explore the Efficacy and Safety of Risperidone Long-acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder, With Open-label Extension |
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Bipolar Disorder |
| Intervention type | Drug |
| Interventions | Risperdal Consta, Placebo |
| Enrollment | 559 |
| Start date | Feb 1, 2005 |
| Primary completion | Oct 1, 2007 |
| Completion | Dec 1, 2007 |
| First posted | Aug 22, 2005 |
| Last update posted | Jul 29, 2013 |
| Countries | Austria, India, Malaysia, Poland, Russia, Slovakia, Spain, Taiwan, Ukraine, United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: