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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 Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00182078: Completed Phase 4 study of Depression and Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
NCT00182078 is a Phase 4 study of Depression and Post Traumatic 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00182078, a Phase 4 study of Depression and Post Traumatic 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.
Primary Outcome
The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.
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 |
What the finished NCT00182078 record still lists
NCT00182078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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, Post Traumatic 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.
Learn More About Clinical Trials
Similar trials for Depression
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 NCT00182078's enrollment target sits among peer trials
26 583rd of 679 higher than 94 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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