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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of D-cycloserine on Treatment of PTSD in Youth

Conditions
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Posttraumatic Stress Disorders, PTSD

Intervention / Treatment
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* Drug: D-cycloserine
* Drug: Placebo pill
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D-cycloserine plus CBT<br>Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. | Drug: D-cycloserine<br>* D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.<br>* Other names: Seromycin (brand name);Behavioral: CBT<br>* 12-session CBT protocol, called Youth PTSD Treatment.<br>* Other names: cognitive behavioral therapy;|
| Placebo Comparator: Placebo plus CBT<br>Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill. | Drug: Placebo pill<br>* Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.<br>Behavioral: CBT<br>* 12-session CBT protocol, called Youth PTSD Treatment.<br>* Other names: cognitive behavioral therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child PTSD Symptom Scale (CPSS) | 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). | After 12 therapy sessions, up to 28 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavior Therapy, Children, Pharmacotherapy