Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study
| Autor: | Stephen Kaplita, Gary S. Sachs, Taro Iwamoto, Raymond Sanchez, Ronald N. Marcus, Cheryl Impellizzeri, Robert D. McQuade, Elyse Stock, Linda Rollin, William H. Carson, Neveen Abou-Gharbia |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Bipolar Disorder Bipolar I disorder Aripiprazole Placebo-controlled study Quinolones Placebo Partial agonist Piperazines Electrocardiography Double-Blind Method Internal medicine medicine Humans Pharmacology (medical) Bipolar disorder Pharmacology Body Weight Middle Aged medicine.disease Prolactin Psychiatry and Mental health Tolerability Anesthesia Female medicine.symptom Psychology Mania Antipsychotic Agents medicine.drug |
| Zdroj: | Journal of Psychopharmacology. 20:536-546 |
| ISSN: | 1461-7285 0269-8811 |
| Popis: | This study compares the efficacy, safety, and tolerability of a partial dopamine agonist, aripiprazole, with placebo in the treatment of patients with bipolar I disorder experiencing an acute manic or mixed episode. In total, 272 hospitalized patients were randomized to aripiprazole 30mg/day or placebo in this 3-week, double-blind, placebo-controlled trial. Dosing could be reduced to 15mg/day for tolerability and, subsequently, increased to 30mg/day based on clinical response. Primary efficacy measure was mean change from baseline to endpoint in Young Mania Rating Scale (YMRS) total score; response was defined as 50% decrease from baseline YMRS score. Aripiprazole-treated patients demonstrated significantly greater improvement from baseline to endpoint in mean YMRS total scores compared with placebo-treated patients as early as Day 4 and sustained through Week 3. A significantly higher response rate was observed in aripiprazole-treated patients (53% vs. 32% at endpoint). Aripiprazole produced significantly greater improvements from baseline on other efficacy assessments compared with placebo, including Clinical Global Impression – Bipolar Version Severity and Improvement scores. The 30mg/day dose was maintained by 85% of aripiprazole-treated patients. Incidence of discontinuations due to adverse events was similar for aripiprazole (8.8%) and placebo (7.5%). Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight and was not associated with elevated serum prolactin or QTc prolongation. In conclusion, aripiprazole demonstrated superior efficacy to placebo in the treatment of patients with bipolar I disorder presenting with acute manic or mixed episodes, and exhibited a favourable safety and tolerability profile. |
| Databáze: | OpenAIRE |
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