A Double-Blind, Randomized, Placebo-Controlled Study of Quetiapine as Adjunctive Treatment for Adolescent Mania
| Autor: | Michael L. Schwiers, Stephen M. Strakowski, Melissa P. DelBello, H. Lee Rosenberg |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Male
Divalproex Dibenzothiazepines medicine.medical_specialty Bipolar Disorder Adolescent medicine.drug_class Young Mania Rating Scale Quetiapine Fumarate Double-Blind Method Antimanic Agents Internal medicine Bipolar disorder in children mental disorders Developmental and Educational Psychology medicine Humans Child Psychiatry Analysis of Variance Valproic Acid Mood stabilizer medicine.disease Psychiatry and Mental health Tolerability Acute Disease Adjunctive treatment Quetiapine Drug Therapy Combination Female medicine.symptom Psychology Mania medicine.drug |
| Zdroj: | Journal of the American Academy of Child & Adolescent Psychiatry. 41:1216-1223 |
| ISSN: | 0890-8567 |
| DOI: | 10.1097/00004583-200210000-00011 |
| Popis: | Objective: This randomized, double-blind, placebo-controlled study examined the efficacy and tolerability of quetiapine in combination with divalproex (DVP) for acute mania in adolescents with bipolar disorder. It was hypothesized that DVP in combination with quetiapine would be more effective than DVP alone for treating mania associated with adolescent bipolar disorder. Furthermore, it was hypothesized that quetiapine would be well tolerated. Method: Thirty manic or mixed bipolar I adolescents (12–18 years) received an initial DVP dose of 20 mg/kg and were randomly assigned to 6 weeks of combination therapy with quetiapine, which was titrated to 450 mg/day ( n = 15) or placebo ( n = 15). Primary efficacy measures were change from baseline to endpoint in Young Mania Rating Scale (YMRS) score and YMRS response rate. Safety and tolerability were assessed weekly. Results: The DVP + quetiapine group demonstrated a statistically significantly greater reduction in YMRS scores from baseline to endpoint than the DVP + placebo group ( F 1,27 = 5.04, p = .03). Moreover, YMRS response rate was significantly greater in the DVP + quetiapine group than in the DVP + placebo group (87% versus 53%; Fisher exact test, p = .05). No significant group differences from baseline to endpoint in safety measures were noted. Sedation, rated as mild or moderate, was significantly more common in the DVP + quetiapine group than in the DVP + placebo group. Conclusions: The findings of this study indicate that quetiapine in combination with DVP is more effective for the treatment of adolescent bipolar mania than DVP alone. In addition, the results suggest that quetiapine is well tolerated when used in combination with DVP for the treatment of mania. |
| Databáze: | OpenAIRE |
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