D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents

Overview

The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 13-18 year-old children.

Full Title of Study: “D-cycloserine Adjunctive Treatment for PTSD in Adolescents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2012

Detailed Description

While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances. D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up.

Interventions

  • Drug: D-cycloserine
    • D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
  • Drug: Placebo pill
    • Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.
  • Behavioral: CBT
    • 12-session CBT protocol, called Youth PTSD Treatment.

Arms, Groups and Cohorts

  • Active Comparator: D-cycloserine plus CBT
    • Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
  • Placebo Comparator: Placebo pill
    • Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.

Clinical Trial Outcome Measures

Primary Measures

  • Child PTSD Symptom Scale (CPSS)
    • Time Frame: After 12 therapy sessions, up to 28 weeks.
    • The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).

Participating in This Clinical Trial

Inclusion Criteria

  • Certain number of PTSD symptoms plus functional impairment – Must be able to swallow pills Exclusion Criteria:

  • Serious kidney or liver disease – Epilepsy – Bipolar disorder – Psychosis

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tulane University School of Medicine
  • Collaborator
    • National Alliance for Research on Schizophrenia and Depression
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael S. Scheeringa, Professor – Tulane University School of Medicine
  • Overall Official(s)
    • Michael S Scheeringa, MD, MPH, Principal Investigator, Tulane University School of Medicine

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