Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESAn Open-Label Trial of Divalproex in Children and Adolescents With Bipolar Disorder
Section snippets
Study Design
Child and adolescent inpatients and outpatients were recruited from five academic medical centers for participation in the study. The study was approved by the Institutional Review Boards at each of the sites, and informed consent from the parent and assent from the child were obtained before participation in the study. During a 1-week screening period, subjects were evaluated for eligibility via physical examination, vital signs, hematology tests, blood chemistry tests, medical and psychiatric
Subjects
Forty subjects entered the open-label period of the study. Subject characteristics are presented in Table 1. The mean age of subjects was 12.1 years (SD = 3.62), and median duration of study drug exposure was 33.5 days (range 2–122). The mean divalproex dosage at the final visit was 813 mg/day (SD = 338; 17.5 mg/kg per day [SD = 8.2]), with a mean serum valproate level at the final visit of 83.4 μg/mL (SD = 25.4, n = 37).
Four subjects (10%) began therapy with lithium carbonate on or after day
DISCUSSION
This is the largest open-label study of divalproex treatment for children and adolescents with bipolar disorder. In this study, 61% of the subjects showed a ≥50% improvement from baseline in MRS scores. This response rate is similar to the response rate found by Kowatch et al. (2000) in their open-label comparison of divalproex, lithium, and carbamazepine. The time course of response was fairly rapid, with some improvement shown within the first week of treatment. Symptoms continued to decline
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Pharmacological Therapies in Children and Adolescents
2022, Comprehensive Clinical Psychology, Second EditionMixed States in Early-Onset Bipolar Disorder
2020, Psychiatric Clinics of North AmericaPsychopharmacology of Bipolar Disorders in Children and Adolescents
2017, Pediatric Clinics of North AmericaCitation Excerpt :Divalproex is approved by the FDA for the treatment of manic and/or mixed episodes in adults, but not in youth. There are several positive open-label studies and a chart review suggesting the benefit of divalproex in the treatment of manic/mixed states.12–14 A double-blind study compared divalproex with quetiapine in treating acute mania and showed higher response with quetiapine.12
Pharmacologic Treatment of Bipolar Disorder in Children and Adolescents
2012, Child and Adolescent Psychiatric Clinics of North AmericaCitation Excerpt :Important limitations of this preliminary study include a small sample size, discontinuation before recovery, and rapid discontinuation. Small, open-label trials of DVPX in acute pediatric mania have reported response rates ranging from 53% to 75%.50–52 A large (N = 150; 10–17 years old) 4-week industry-sponsored multicenter study found a similar response rate for DVPX (24%) and placebo (23%).53
Risperidone and divalproex differentially engage the fronto-striato- temporal circuitry in pediatric mania: A pharmacological functional magnetic resonance imaging study
2012, Journal of the American Academy of Child and Adolescent Psychiatry
Support for this study was provided by Abbott Laboratories.