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NCT00571688 · ClinicalTrials.gov registry record · Phase 4
Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
A Phase 4 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT00571688: Completed Phase 4 study, sponsored by Vanderbilt University.
NCT00571688 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00571688, a Phase 4 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
The outcome was total number of events divided by number of months (normalized to unit time). This was be calculated by dividing the number of relapse related events by the number of months of participation. Relapse related events included: (1) YMRS score \> 14 or MADRS \> 15; (2) 20% or greater increase in the YMRS or MADRS scores from the previous study visit; (3) urgent care visit (psychiatric hospitalization; emergency department visit; referral for respite care, partial hospitalization, or
Interventions
- DRUG Treatment as usual
- DRUG Risperdal (risperidone) Consta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
What the finished NCT00571688 record still lists
NCT00571688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Treatment as usual is the first listed.
NCT00571688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00571688 about?
NCT00571688 is a clinical study titled "Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?". 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 injection...
What is the current status of trial NCT00571688?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2007-11. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00571688?
The interventions under investigation include: Treatment as usual (DRUG), Risperdal (risperidone) Consta (DRUG).
Who is sponsoring clinical trial NCT00571688?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00571688's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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