Effect of D-cycloserine on Treatment of PTSD in Youth
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Child PTSD Symptom Scale (CPSS)
Study Overview
Brief Summary
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 7-12 year old children.
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 assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Certain number of PTSD symptoms plus functional impairment
- •Must be able to swallow pills
Exclusion Criteria
- •Serious kidney or liver disease
- •Psychosis
Arms & Interventions
D-cycloserine plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
Intervention: D-cycloserine (Drug)
D-cycloserine plus CBT
Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
Intervention: CBT (Behavioral)
Placebo plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Intervention: Placebo pill (Drug)
Placebo plus CBT
Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Intervention: CBT (Behavioral)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael S. Scheeringa
Professor
Tulane University School of Medicine