At a glance
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1/2 D-cycloserine Augmentation of CBT for Pediatric OCD
In Brief
A Phase 3 clinical trial evaluating Cognitive-behavioral therapy, d-cycloserine, and 1 other intervention for Obsessive-compulsive Disorder. Completed, enrolled 142 participants across 2 sites.
Detailed Summary
The investigators are conducting a randomized double-blind placebo-controlled study to assess the efficacy of d-cycloserine augmentation of cognitive-behavioral therapy for the treatment of pediatric obsessive compulsive disorder. This study represents an innovative approach in translating bench research findings into clinical research and testing a new approach for optimizing an effective psychotherapy with a safe non-psychotropic medication.
Study Details
Timeline
Interventions
All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg). Accordingly, doses for this study will be about 0.7mg/kg. Two dosing levels will be used based upon weight ranges to ensure comparable mg/kg levels: children weighing 25-45kg will be given a dosage of 25mg (\~0.56-1.0 mg/kg/day), and children ≥46kg will be given 50mg provided in two 25mg capsules (\~0.50-1.08mg/kg/day). Doses will be given 1 hour before therapy sessions 4-10.
The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).