Divalproex Sodium -ER in Outpatients with Disruptive Behavior Disorders: A Three Month Open Label Study
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This aim of this clinical trial was to study the effects of divalproex sodium (DVPX) in reducing Reactive/Affective/ Defensive/ Impulsive Aggression (RADI) in youth with Disruptive Behavior Disorders (DBD) in an outpatient clinic over a period of 3 months. We recruited forty participants with Oppositional Defiant Disorder or Conduct Disorder. Twenty participants received 12 weeks of openly titrated DVPX, whereas twenty participants served as a comparison control group. Primary efficacy measures were the Clinical Global Improvement-Severity (CGI-S) and CGI-C (Change) scales; secondary efficacy measures included standardized measures of aggression. Based on the CGI-S and CGI-C ratings, the DVPX group showed significant improvement by the last observation. Attrition rates were notably high, which is not surprising given the clinical population studied. This study provides further support for the efficacy of DVPX in decreasing RADI aggression in the context of DBD. These results are particularly noteworthy because the sociotherapeutic structures supporting patients in previous trials were not present.
KeywordsDisruptive behavior disorders Divalproex sodium Children and adolescents Outpatients
This study was supported by grants to Dr. Steiner by Abbott Pharmaceuticals; The California Wellness Foundation; and the Eucalyptus Foundation. This study was supported by a research fellowship to Dr. Saxena, namely, the American Psychiatric Association Program for Minority Research Training in Psychiatry (APA PMRTP). The authors also thank the following individuals for their contributions in data collection and analyses: Sanja Medic, M.A.., Kelly Caywood, Ph.D. and Abby Durkin, B.A.
- 2.Daniel F Connor (2002) In: Aggression and antisocial behavior in children and adolescents: research and treatment. Guilford Press, New York, p 480Google Scholar
- 5.Connor DF, Carlson GA, Chang KD, Daniolos PT, Ferziger R, Findling RL, Hutchinson JG, Malone RP, Halperin JM, Plattner B, Post RM, Reynolds DL, Rogers KM, Saxena K, Steiner H, Stanford/Howard/AACAP Workgroup on Juvenile Impulsivity and Aggression (2006) Juvenile maladaptive aggression: a review of prevention, treatment, and service configuration and a proposed research agenda. J Clin Psychiatry 67:808–820CrossRefPubMedGoogle Scholar
- 8.Klein RG (1991) Preliminary results: lithium effects in conduct disorders. In: CME Syllabus and Proceedings Summary of the 144th annual meeting of the American Psychiatric Association, New Orleans. Symposium 2:119–120Google Scholar
- 9.Campbell M, Silva RR, Kafantaris V, Locascio JJ, Gonzalez NM, Lee D, Lynch NS (1991) Predictors of side effects associated with lithium administration in children. Psychopharm Bulletin 27:373–380Google Scholar
- 26.Geller B, Zimerman B, Williams M, Bolhofner K, Craney JL, DelBello MP, Soutullo C (2001) Reliability of the Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia (WASH-U-KSADS) mania and rapid cycling sections. J Am Acad Child Adolesc Psychiatry 40:450–455CrossRefPubMedGoogle Scholar
- 27.Guy W (1976) ECDEU Manual for Psychopharmacology. In: Publication 76-338. National Institute of Mental Health, US Department of Health, Education and Welfare Press, Washington, pp 113–147, 534–537Google Scholar
- 28.Steiner H, Karnik NS (2009). Integrated treatment of aggression in the context of ADHD in children refractory to stimulant monotherapy: a window into the future of child psychopharmacology. Editorial, Am J Psychiatry, 166Google Scholar