A Study of Sertraline to Prevent PTSD - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00182078

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of Sertraline to Prevent PTSD

Resource links provided by NLM:

MedlinePlus related topics: Burns Depression Post-Traumatic Stress Disorder Surgery

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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: Placebo Comparator 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.
Sertraline: Experimental 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.

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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:

American Academy of Child and Adolescent Psychiatry This link exits the ClinicalTrials.gov site

American Psychiatric Association This link exits the ClinicalTrials.gov site

Publications:

Saxe GN, Stoddard F, Hall E, Chawla N, Lopez C, Sheridan R, King D, King L, Yehuda R. Pathways to PTSD, part I: Children with burns. Am J Psychiatry. 2005 Jul;162(7):1299-304.

Stoddard FJ, Saxe G. Ten-year research review of physical injuries. J Am Acad Child Adolesc Psychiatry. 2001 Oct;40(10):1128-45. Review.

Saxe G, Stoddard F, Courtney D, Cunningham K, Chawla N, Sheridan R, King D, King L. Relationship between acute morphine and the course of PTSD in children with burns. J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):915-21.

Stoddard FJ, Sheridan RL, Saxe GN, King BS, King BH, Chedekel DS, Schnitzer JJ, Martyn JA. Treatment of pain in acutely burned children. J Burn Care Rehabil. 2002 Mar-Apr;23(2):135-56. Review.

Saxe G, Chawla N, Stoddard F, Kassam-Adams N, Courtney D, Cunningham K, Lopez C, Hall E, Sheridan R, King D, King L. Child Stress Disorders Checklist: a measure of ASD and PTSD in children. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):972-8.

Stoddard FJ, Todres ID. A new frontier: posttraumatic stress and its prevention, diagnosis, and treatment. Crit Care Med. 2001 Mar;29(3):687-8. Review. No abstract available.

Stoddard FJ, Usher CT, Abrams AN. Psychopharmacology in pediatric critical care. Child Adolesc Psychiatr Clin N Am. 2006 Jul;15(3):611-55. Review.

Responsible Party:	Massachusetts General Hospital ( Frederick J. Stoddard Jr., M.D. )
Study ID Numbers:	SHC Grant No. 8840, SHC Grant No. 8840
Study First Received:	September 14, 2005
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00182078 History of Changes
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:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Stress Disorders, Traumatic

Behavioral Symptoms
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Mood Disorders
Stress Disorders, Post-Traumatic
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010