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NCT00704379 · ClinicalTrials.gov registry record · Phase 2
Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
A Phase 2 study of Traumatic Brain Injury, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT00704379: Completed Phase 2 study of Traumatic Brain Injury, sponsored by Baylor College of Medicine.
NCT00704379 is a Phase 2 study of Traumatic Brain Injury that has completed, run by Baylor College of Medicine. The registered enrollment target is 94 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00704379, a Phase 2 study of Traumatic Brain Injury, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.
Primary Outcome
Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode \[MDE\] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder). On the other ha
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sertraline
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2008-06 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT00704379 record still lists
NCT00704379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00704379 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00704379 about?
NCT00704379 is a clinical study titled "Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury". The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.
What is the current status of trial NCT00704379?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2008-06. Estimated completion is 2014-04.
What conditions does trial NCT00704379 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT00704379?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT00704379?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00704379 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00704379's enrollment target sits among peer trials
94 76th of 171 higher than 95 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury 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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