Is Asenapine More Effective than Other Interventions in the Treatment of Adult Patients with Bipolar I Disorder

OBJECTIVE: The objective of this selective EBM review is to determine whether or not Asenapine is more effective than other interventions in the treatment of adult patients with bipolar I disorder. STUDY DESIGN: Review of three English language primary randomized controlled trial studies published from 2009-2010. DATA SOURCES: Three randomized controlled trials studying the effectiveness of Asenapine in the treatment of mania in adult patients with bipolar I disorder in comparison to other interventions. OUTCOME MEASURED: Outcomes measured were reduction in severity of manic symptoms and tolerability of the medication. The severity of manic symptoms was measured using the Young Mania Rating Scale (YMRS). The YMRS is a self report questionnaire completed by the patients. It includes rating scales for elevated mood, increased motor activity and energy, sexual interest, sleep, irritability, speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Tolerability was based on adverse event assessment categorized in terms of maximum intensity and the investigator’s opinion of the relationship to the trial medication used. RESULTS: The articles reviewed showed Asenapine was not more effective than Olazapine and had mixed results when compared to placebo. The McIntyre 2009 3 week study showed Asenapine to be superior to placebo in YMRS response. The McIntyre 2010 3 week study showed Asenapine to be nonsuperior over placebo and inferior to Olanzapine in YMRS response. The McIntyre 2009 9 week extension study showed Asenapine to be noninferior to Olanzapine in YMRS response. Asenapine was well tolerated. CONCLUSIONS: Based on the articles reviewed, it is unclear how effective Asenapine is in YMRS response rates. It may be a potential option for the treatment of mania in patients diagnosed with bipolar I disorder, but more research is needed.