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NCT01821690 · ClinicalTrials.gov registry record · Phase 4
Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT01821690: Completed Phase 4 study, sponsored by Indiana University.
NCT01821690 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821690, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
The purpose of this study is to improve behavior control displayed by persons with traumatic brain injury by assessing effectiveness of treatments for post-TBI irritability and aggression.
Primary Outcome
Neuropsychiatric Inventory (NPI) is a 40-item instrument evaluating 12 behavioral domains with prior use in TBI. NPI-Irritability domain (NPI-I) encompasses temper outbursts, mood fluctuations, abrupt anger, impatience, irritable disposition, and argumentative behavior. Assessment involves identifying if these behaviors are present and then scoring the most concerning manifestation on severity (1=mild to 3=severe) and frequency (1-4 scale, higher=greater occurrence). Domain totals (0-12 range) r
Interventions
- DRUG Placebo
- DRUG Buspirone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-05-15 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 4 |
What the finished NCT01821690 record still lists
NCT01821690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01821690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01821690 about?
NCT01821690 is a clinical study titled "Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression". The purpose of this study is to improve behavior control displayed by persons with traumatic brain injury by assessing effectiveness of treatments for post-TBI irritability and aggression.
What is the current status of trial NCT01821690?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2013-05-15. Estimated completion is 2025-09-26.
What interventions are being tested in trial NCT01821690?
The interventions under investigation include: Placebo (DRUG), Buspirone (DRUG).
Who is sponsoring clinical trial NCT01821690?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01821690's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 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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