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NCT00182078 · ClinicalTrials.gov registry record · Phase 4
A Study of Sertraline to Prevent PTSD
A Phase 4 study of Depression and Posttraumatic Stress Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00182078 is a Phase 4 study of Depression and Posttraumatic Stress Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 26 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00182078, a Phase 4 study of Depression and Posttraumatic Stress Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-burn injury. This study is investigating the early use of a medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1 and 2: To assess the efficacy of sertraline to prevent the development of (Aim 1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared with placebo. This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and families are evaluated for the presence of acute stress symptoms. Children are reassessed in a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of the study and again at 18 weeks (the midpoint of the study). At each reassessment, information is collected on the child's compliance with the study medication, the parents' assessment of the child's functioning, and the child's self-report of posttraumatic and depressive symptomatology. The main outcome variable used in this study is the child's posttraumatic symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sertraline
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2002-11 |
| Est. Completion | 2006-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00182078
The ClinicalTrials.gov registry entry for NCT00182078 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00182078 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00182078 about?
NCT00182078 is a clinical study titled "A Study of Sertraline to Prevent PTSD". The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-burn injury. This study is investigating the early use of a medication in the prevention of posttraumat...
What is the current status of trial NCT00182078?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2002-11. Estimated completion is 2006-07.
What conditions does trial NCT00182078 study?
This clinical trial studies the following conditions: Depression, Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT00182078?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT00182078?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00182078 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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