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

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

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

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
Volume19
Issue number1
DOIs
StatePublished - Jan 1 2009

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Valproic Acid
Bipolar Disorder
Safety
Diagnostic and Statistical Manual of Mental Disorders
Appetite
Ammonia
Nausea
Caregivers
Weight Gain
Healthy Volunteers

ASJC Scopus subject areas

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

Cite this

Long-term safety of divalproex sodium extended-release in children and adolescents with bipolar I disorder. / Redden, Laura; Delbello, Melissa; Wagner, Karen; Wilens, Timothy E.; Malhotra, Shishuka; Wozniak, Patricia; Vigna, Namita V.; Greco, Nicholas; Kovacs, Xenia; Abi-Saab, Walid; Saltarelli, Mario.

In: Journal of Child and Adolescent Psychopharmacology, Vol. 19, No. 1, 01.01.2009, p. 83-89.

Research output: Contribution to journalArticle

Redden, L, Delbello, M, Wagner, K, Wilens, TE, Malhotra, S, Wozniak, P, Vigna, NV, Greco, N, Kovacs, X, Abi-Saab, W & Saltarelli, M 2009, 'Long-term safety of divalproex sodium extended-release in children and adolescents with bipolar I disorder', Journal of Child and Adolescent Psychopharmacology, vol. 19, no. 1, pp. 83-89. https://doi.org/10.1089/cap.2008.0106
Redden, Laura ; Delbello, Melissa ; Wagner, Karen ; Wilens, Timothy E. ; Malhotra, Shishuka ; Wozniak, Patricia ; Vigna, Namita V. ; Greco, Nicholas ; Kovacs, Xenia ; Abi-Saab, Walid ; Saltarelli, Mario. / Long-term safety of divalproex sodium extended-release in children and adolescents with bipolar I disorder. In: Journal of Child and Adolescent Psychopharmacology. 2009 ; Vol. 19, No. 1. pp. 83-89.
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