Randomized, Double-Blind, Placebo-Controlled Study of Divalproex Extended Release Loading Monotherapy in Ambulatory Bipolar Spectrum Disorder Patients With Moderate-to-Severe Hypomania or Mild Mania
| Autor: | Paul E. Keck, Jeffrey A. Welge, Lena Jefferson, Anna I. Guerdjikova, Ryan S. Creech, Brian E. Martens, Susan L. McElroy |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male Divalproex medicine.medical_specialty Bipolar Disorder Placebo-controlled study Young Mania Rating Scale Placebo Severity of Illness Index Double-Blind Method Antimanic Agents Internal medicine medicine Humans Psychiatry Psychiatric Status Rating Scales Valproic Acid Psychiatry and Mental health Treatment Outcome Hypomania Tolerability Delayed-Action Preparations Ambulatory Female medicine.symptom Psychology Mania |
| Zdroj: | The Journal of Clinical Psychiatry. 71:557-565 |
| ISSN: | 0160-6689 |
| Popis: | OBJECTIVE To determine whether divalproex extended release (ER) would be effective in outpatients with DSM-IV-TR-diagnosed ambulatory bipolar spectrum disorder (BSD) and moderate-to-severe hypomanic or mild manic symptoms (hypomania/mild mania). METHOD An 8-week, randomized, double-blind, placebo-controlled trial of divalproex ER oral loading (begun at 15 mg/kg/d and titrated to a maximum of 30 mg/kg/d) in ambulatory BSD with hypomania/mild mania patients, operationally defined as a Young Mania Rating Scale (YMRS) score >or= 10 but < 21 at baseline and at 1 other study visit at least 3 days apart over the 2 weeks before baseline, was conducted. Patients were enrolled from October 2003 through November 2007. RESULTS Sixty patients (n = 30 in the divalproex ER group) had at least 1 postbaseline assessment. The divalproex ER group showed a significantly greater rate of reduction in mean total YMRS score than the placebo group (longitudinal analysis, P = .024). The divalproex ER group also showed more improvement in depressive symptoms the greater the severity of baseline depression (P = .11 for analysis of covariance treatment-by-baseline interaction). Baseline-to-endpoint change scores using last-observation-carried-forward showed that divalproex ER was associated with a marginally significant change in mean total YMRS score (P = .080). Comparable numbers of patients discontinued divalproex ER (n = 17) and placebo (n = 15), including those that discontinued use because of adverse events (n = 4 and 3, respectively). CONCLUSIONS Divalproex ER begun at 15 mg/kg/d was superior to placebo in reducing hypomanic/mild manic symptoms in ambulatory BSD. It was associated with fairly good tolerability but a high discontinuation rate. Controlled trials of divalproex ER and other mood stabilizers in larger groups of ambulatory BSD patients with hypomanic/mild manic symptoms appear warranted. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00278772. |
| Databáze: | OpenAIRE |
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