Efficacy of Augmentation of Cognitive Behavior Therapy With Weight-Adjusted d-Cycloserine vs Placebo in Pediatric Obsessive-Compulsive Disorder: A Randomized Clinical Trial

摘要: Importance Cognitive behavior therapy (CBT) among youth with obsessive-compulsive disorder (OCD) is effective, but many patients remain symptomatic after intervention.d-cycloserine, a partial agonist at theN-methyl-d-aspartate receptor in the amygdala, has been associated enhanced CBT outcome for OCD adults requires evaluation youth. Objectives To examine relative efficacy of weight-adjustedd-cycloserine (25 or 50 mg) vs placebo augmentation and to assess if concomitant antidepressant medication moderated effects. Design, Setting, Participants In placebo-controlled randomized clinical trial, 142 youths (age range, 7-17 years) enrolled between June 1, 2011, January 30, 2015, 2 academic health science centers (University South Florida Massachusetts General Hospital) primary diagnosis were double-blind fashion tod-cycloserine plus CBT. Intent-to-treat analysis was performed. Interventions Patients randomly assigned 1:1 ratio either 10 sessions ofd-cycloserine CBT.d-cycloserine taken 1 hour before 4 through 10. Main Outcomes Measures Children’s Yale-Brown Obsessive Compulsive Scale randomization, biweekly, midtreatment, posttreatment. Secondary outcomes included Clinical Global Impressions–Severity Impressions–Improvement, remission status, Depression Rating Scale, Multidimensional Anxiety Children, Obsessive-Compulsive Impact Scale–Parent Version. Results The study cohort comprised participants. Their mean (SD) age 12.7 (2.9) years, 53.5% (76 142) female. A mixed-effects model using all available data indicated significant declines total score Impressions–Severity. No interaction treatment group changes that thed-cycloserine declined similar rates per assessment point on (estimate, −2.31, 95% CI, −2.79 −1.83 estimate, −2.03, −2.47 −1.58, respectively) −0.29, −0.35 −0.22 −0.23, −0.29 −0.17, respectively). differences secondary present. Antidepressant use baseline did not moderate group. Conclusions Relevance d-cycloserine confer additional benefit OCD. Other approaches should be examined enhance outcome. Trial Registration clinicaltrials.gov Identifier:NCT00864123