D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)

PHASE3CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2017

Conditions
Obsessive-compulsive Disorder
Interventions
BEHAVIORAL

Cognitive-behavioral therapy

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.

DRUG

d-cycloserine

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.

DRUG

Pill placebo

The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).

Trial Locations (2)

33701

University of South Florida, St. Petersburg

02138

Massachusetts General Hospital, Cambridge

All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

lead

University of South Florida

OTHER

NCT01411774 - D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD) | Biotech Hunter | Biotech Hunter