A Study of Sertraline to Prevent PTSD
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorder Depression |
Drug: Sertraline (drug) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Study of Sertraline to Prevent PTSD |
- Post-traumatic stress symptoms [ Time Frame: Baseline, Week 8, Week 12, and Week 24 ] [ Designated as safety issue: Yes ]
- Depressive symptoms [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 24 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
|
|
Experimental: Sertraline
Sertraline
|
Drug: Sertraline (drug)
The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn
- Between the ages of 6 - 20 years
- Recent experience of an acute burn, injury, or surgery meeting the DSM-IV AI stressor criterion
- Child's response to the stressor meets DSM-IV A2 response criterion
- Proficiency in either English or Spanish
Exclusion Criteria:
- No memory of the injury
- Current use of an anti-depressant
- Known hypersensitivity to sertraline
- Diagnosis of Bipolar Disorder
- Diagnosis of PTSD
- Mental Retardation
- Traumatic Brain Injury
- New onset or marked worsening of a seizure disorder
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Frederick J Stoddard, M.D. | Massachusetts General Hospital |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Frederick J. Stoddard Jr., M.D., Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00182078 History of Changes |
| Other Study ID Numbers: | SHC Grant No. 8840, SHC Grant No. 8840 |
| Study First Received: | September 14, 2005 |
| Last Updated: | August 7, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
sertraline children adolescents posttraumatic stress disorder |
depression prevention burns injuries |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders Sertraline Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013