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.


METHODS
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.


CONCLUSIONS
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.
Steiner
Hans
H
Division of Child Psychiatry and Child Development, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA 94305-5719, USA. steiner@stanford.edu
Petersen
Maya L
ML
Saxena
Kirti
K
Ford
Sekou
S
Matthews
Zakee
Z
D000293:Adolescent; D000374:Aggression / Q000187:drug effects; D000786:Anger / Q000187:drug effects; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D001143:Arousal / Q000187:drug effects; D019955:Conduct Disorder / Q000175:diagnosis / Q000188:drug therapy*; D003415:Crime / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D007389:Internal-External Control; D007604:Juvenile Delinquency / Q000534:rehabilitation; D008297:Male; D010552:Personality Assessment; D010555:Personality Inventory; D012114:Residential Treatment; D012951:Socialization; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage* / Q000009:adverse effects
D000927:Anticonvulsants; D014635:Valproic Acid