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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 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants.

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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.

Interventions

  • DRUG Treatment as usual
  • DRUG Risperdal (risperidone) Consta

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2007-11
Est. Completion 2009-02
Phase Phase 4

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT00571688

The ClinicalTrials.gov registry entry for NCT00571688 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Treatment as usual is the first listed.

NCT00571688 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.