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NCT00099983 · ClinicalTrials.gov registry record · Phase 2
Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
NCT00099983: Completed Phase 2 study, sponsored by US Department of Veterans Affairs.
NCT00099983 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00099983, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
Study Summary
The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a placebo-controlled study, meaning that half of the participants will be assigned to receive a pill that contains no drug. The treatment phase of the study will last for 6 months, during which time participants will continue to receive all their usual treatments in addition to the study treatment and will be asked to complete procedures and assessments (questionnaires, interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various points within the 6-month treatment phase. At the end of the 6-month study, participants will discontinue the study treatment.
Primary Outcome
The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.
Interventions
- DRUG Placebo
- DRUG Risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2006-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT00099983 record still lists
NCT00099983 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00099983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00099983 about?
NCT00099983 is a clinical study titled "Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder". The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a placebo-controlled study, meaning that half of the participants will be assigned to receive a pill that contains no drug. The tre...
What is the current status of trial NCT00099983?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2006-10. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00099983?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG).
Who is sponsoring clinical trial NCT00099983?
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 NCT00099983's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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