Long-term safety of divalproex sodium extended-release in children and adolescents with bipolar I disorder

Laura Redden, Melissa Delbello, Karen Dineen Wagner, Timothy E. Wilens, Shishuka Malhotra, Patricia Wozniak, Namita V. Vigna, Nicholas Greco, Xenia Kovacs, Walid Abi-Saab, Mario Saltarelli

Research output: Contribution to journalArticlepeer-review

29 Scopus citations


Objective: The objective of this open-label study was to assess the safety of divalproex sodium extended-release in the treatment of children and adolescents with acute mania associated with bipolar I disorder. Methods: This was a 6-month, Phase 3, open-label study in healthy subjects aged 9-17 years with a current Diagnostic and Statistical Manual of Mental Disorders, 4 th edition, Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder manic or mixed episode. Divalproex sodium extended-release (DVPX-ER) was initiated at 15 mg/kg per day on day 1 (not to exceed 750 mg/day) with increases allowed to a maximum of 35 mg/kg per day. Study visits were conducted on day 1 and at months 1, 2, 3, and 6. Assessments included standard safety evaluations and appropriate rating scales for clinical effect. Results: A total of 226 subjects were enrolled; 109 subjects completed the study. The most common adverse events were weight gain (16%), nausea (9%), and increased appetite (8%). Nonsymptomatic elevations of mean ammonia levels in plasma were observed. The mean Young Mania Rating Scale (YMRS) decreased 12.4 from baseline to final visit; small improvements were seen in behavior and caregiver stress ratings. Conclusions: DVPX-ER was generally well tolerated in children and adolescents with acute mania, with a side-effect profile similar to that observed in adults.

Original languageEnglish (US)
Pages (from-to)83-89
Number of pages7
JournalJournal of Child and Adolescent Psychopharmacology
Issue number1
StatePublished - Jan 1 2009

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Pharmacology (medical)


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