Long-term safety of divalproex sodium extended-release in children and adolescents with bipolar I disorder
| Autor: | 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, Juanita Lynn, Taylor |
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| Rok vydání: | 2009 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Bipolar I disorder Bipolar Disorder genetic structures Adolescent Acute mania MEDLINE Antimanic Agents mental disorders medicine Divalproex Sodium Humans Pharmacology (medical) Psychiatry Child Psychiatric Status Rating Scales business.industry Valproic Acid medicine.disease Clinical trial Psychiatry and Mental health Delayed-Action Preparations Pediatrics Perinatology and Child Health Psychiatric status rating scales Female Long term safety Extended release business medicine.drug |
| Zdroj: | Journal of child and adolescent psychopharmacology. 19(1) |
| ISSN: | 1557-8992 |
| Popis: | 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.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.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.DVPX-ER was generally well tolerated in children and adolescents with acute mania, with a side-effect profile similar to that observed in adults. |
| Databáze: | OpenAIRE |
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