A Study of Sertraline to Prevent PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederick J. Stoddard, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182078
First received: September 14, 2005
Last updated: July 8, 2014
Last verified: July 2014
  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: Placebo
Drug: Sertraline
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:
  • Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    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.

  • Diagnostic Interview for Children and Adolescents (DICA) - Child [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 children 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.


Secondary Outcome Measures:
  • The Child Depression Inventory (CDI) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined.


Enrollment: 26
Study Start Date: November 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo was administered on a flexible fixed schedule and tapered at 12 weeks.
Drug: Placebo
The placebo was 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 placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
Other Name: Placebo
Experimental: Sertraline
Sertraline was administered on a flexible fixed schedule beginning at 25 mg/day and increasing as high as 150 mg/day. At week 12, the medication was tapered at a rate of 25 mg every 3 days until it was discontinued.
Drug: Sertraline
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.
Other Name: Zoloft

  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 Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion
  • Child's response to the stressor meets Diagnostic and Statistical Manual(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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Responsible Party: Frederick J. Stoddard, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182078     History of Changes
Other Study ID Numbers: SHC Grant No. 8840, SHC Grant No. 8840, Protocol #:2002P001521; MGH
Study First Received: September 14, 2005
Results First Received: June 12, 2012
Last Updated: July 8, 2014
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 August 21, 2014