A Study of Sertraline to Prevent PTSD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182078
First received: September 14, 2005
Last updated: August 7, 2009
Last verified: August 2009
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Post-traumatic stress symptoms [ Time Frame: Baseline, Week 8, Week 12, and Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182078

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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 April 23, 2014