A Study of Sertraline to Prevent PTSD

NCT00182078 | Completed Phase 4 Results DMC

• 2 other identifiers: SHC Grant No. 8840Protocol #:2002P001521; MGH
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Depression

Keywords

sertraline; children; adolescents; posttraumatic stress disorder; depression; prevention; burns; injuries

Outcome Measures

Primary Outcomes (2)

• Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent

  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.

  Baseline to Week 24

• Diagnostic Interview for Children and Adolescents (DICA) - Child

  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.

  Baseline to Week 24

Secondary Outcomes (1)

• The Child Depression Inventory (CDI)

  Baseline to Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo was administered on a flexible fixed schedule and tapered at 12 weeks.

Drug: Placebo

Sertraline

EXPERIMENTAL

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

Interventions

Placebo DRUG

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.

Placebo

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.

Also known as: Zoloft

Sertraline

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• 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. doi: 10.1176/appi.ajp.162.7.1299.

  PMID: 15994712 BACKGROUND

• Stoddard FJ, Saxe G. Ten-year research review of physical injuries. J Am Acad Child Adolesc Psychiatry. 2001 Oct;40(10):1128-45. doi: 10.1097/00004583-200110000-00007.

  PMID: 11589526 BACKGROUND

• 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. doi: 10.1097/00004583-200108000-00013.

  PMID: 11501691 BACKGROUND

• 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. doi: 10.1097/00004630-200203000-00012.

  PMID: 11882804 BACKGROUND

• 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. doi: 10.1097/01.CHI.0000046887.27264.F3.

  PMID: 12874500 BACKGROUND

• Stoddard FJ, Todres ID. A new frontier: posttraumatic stress and its prevention, diagnosis, and treatment. Crit Care Med. 2001 Mar;29(3):687-8. doi: 10.1097/00003246-200103000-00050. No abstract available.

  PMID: 11379543 BACKGROUND

• Stoddard FJ, Usher CT, Abrams AN. Psychopharmacology in pediatric critical care. Child Adolesc Psychiatr Clin N Am. 2006 Jul;15(3):611-55. doi: 10.1016/j.chc.2006.02.005.

  PMID: 16797442 BACKGROUND

• Stoddard FJ Jr, Luthra R, Sorrentino EA, Saxe GN, Drake J, Chang Y, Levine JB, Chedekel DS, Sheridan RL. A randomized controlled trial of sertraline to prevent posttraumatic stress disorder in burned children. J Child Adolesc Psychopharmacol. 2011 Oct;21(5):469-77. doi: 10.1089/cap.2010.0133.

  PMID: 22040192 RESULT

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

  PMID: 38767196 DERIVED

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

  PMID: 35141873 DERIVED

Related Links

• American Academy of Child and Adolescent Psychiatry
• American Psychiatric Association

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Burns; Wounds and Injuries

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

One limitation of this study was the small sample size, due to the challenge of recruiting traumatized children and their parents for participation in a randomized controlled trial of a medication.

Results Point of Contact

• Title: Dr. Frederick J. Stoddard Jr., M.D.
• Organization: Massachusetts General Hospital

fstoddard@partners.org

6173714762

Study Officials

• Frederick J Stoddard, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 5, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-07

Locations

US (1)