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NCT00132678 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 559
- Enrollment target
NCT00132678: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00132678 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 559 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00132678, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 559 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
Primary Outcome
Mood Relapse was defined as: The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score \>12 or a CGI-S score \>4; or a dose increase, or supplementation with oral r
Interventions
- DRUG Placebo
- DRUG Risperdal Consta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 559 participants |
| Start Date | 2005-02 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00132678 record still lists
NCT00132678 is an interventional study that assigns participants to a tested intervention. The registered 559 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00132678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00132678 about?
NCT00132678 is a clinical study titled "A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes". The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
What is the current status of trial NCT00132678?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 559 participants. The study started on 2005-02. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00132678?
The interventions under investigation include: Placebo (DRUG), Risperdal Consta (DRUG).
Who is sponsoring clinical trial NCT00132678?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00132678's enrollment target sits among peer trials
559 673rd of 2000 higher than 1,328 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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