Divalproex sodium for the treatment of conduct disorder: a randomized controlled clinical trial

BACKGROUND: New treatments for conduct disorder are sorely needed. We aimed to test the efficacy of divalproex sodium for the treatment of conduct disorder. METHOD: Seventy-one youths with conduct disorder according to DSM-IV criteria were enrolled in a randomized, controlled, 7-week clinical trial. Subjects were all adolescent males with at least 1 crime conviction. Subjects were randomized into high- and low-dose conditions and were openly managed by a clinical team. Subjects and independent outcome raters were blinded to condition. Clinical Global Impressions-Severity of Illness (CGI-S) and CGI-Improvement (CGI-I) ratings, Weinberger Adjustment Inventory ratings, and staff ratings of behavioral privilege were used to assess outcome. RESULTS: Intent-to-treat analyses showed significant associations between assignment to the high-dose condition and ratings on the CGI-S (p =.02) and CGI-I (p =.0008). Self-reported weekly impulse control was significantly better in the high-dose condition (p <.05), and association between improvement in self-restraint and treatment condition was of borderline statistical significance (p <.06). Parallel analyses comparing outcome by blood drug level achieved strengthened the results, as expected. CONCLUSION: This preliminary study in a most difficult population suggests a role for divalproex sodium in the treatment of conduct disorder. Divalproex sodium improved self-reported impulse control and self-restraint, variables shown to be predictive of criminal recidivism. Studies are needed of longer-term impact and side-effect profiles. This is one of few controlled psychopharmacologic studies of conduct disorder.