Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth

Phase 2

Completed

• Conditions: Posttraumatic Stress Disorders; PTSD
• Interventions: Drug: Placebo pill; Drug: D-cycloserine; Behavioral: CBT

• Registration Number: NCT01157416
• Lead Sponsor: Tulane University School of Medicine

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2016-08-20
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-10
• Last Update Submitted: 2017-03-10
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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
• Psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-cycloserine plus CBT	CBT	Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.
Placebo plus CBT	Placebo pill	Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Placebo plus CBT	CBT	Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
D-cycloserine plus CBT	D-cycloserine	Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.

Primary Outcome Measures

Name	Time	Method
Child PTSD Symptom Scale (CPSS)	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).

Trial Locations

Locations (1)

Tulane University Health Sciences Center, 1440 Canal St.; 🇺🇸 New Orleans, Louisiana, United States