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NCT00132314 · ClinicalTrials.gov registry record · Phase 3
Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 382
- Enrollment target
NCT00132314 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 382 participants.
The verdict
NCT00132314, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 382 participants
- Enrollment target
Study Summary
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.
Interventions
- DRUG IM risperidone
- DRUG oral antipsychotic medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00132314
The ClinicalTrials.gov registry entry for NCT00132314 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IM risperidone is the first listed.
NCT00132314 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00132314 about?
NCT00132314 is a clinical study titled "Long-Acting Injectable Risperidone in the Treatment of Schizophrenia". In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic m...
What is the current status of trial NCT00132314?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2006-09. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00132314?
The interventions under investigation include: IM risperidone (DRUG), oral antipsychotic medication (DRUG).
Who is sponsoring clinical trial NCT00132314?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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