Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by US Department of Veterans Affairs.
NCT00132314 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 382 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.
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 |
What the finished NCT00132314 record still lists
NCT00132314 is an interventional study that assigns participants to a tested intervention. The registered 382 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 (51% lower).
The record links to 0 conditions, and to 2 interventions - of which IM risperidone is the first listed.
NCT00132314 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00132314's enrollment target sits among peer trials
382 978th of 2000 higher than 1,019 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05677490 · 382 participants · Phase 3
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
- NCT06196008 · 382 participants · NA
Telephone-based Physical Activity Coaching or Self Monitored Physical Activity to Improve Physical Function in Older Adults Who Are Undergoing Surgery for Lung Cancer and Their Caregivers
- NCT07100990 · 382 participants · Phase 3
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
- NCT06056830 · 383 participants · Phase 3
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia