Is Cariprazine Effective and Safe in Treating Acute Mania in Bipolar I Disorder?

Objective: The objective of this selective EBM review is to determine whether or not “Is cariprazine effective and safe in treating acute mania in bipolar I disorder?” Study Design: This review is based on three double-blind, randomized controlled trials (RCTs) published in English, in 2015. These studies compared both the efficacy, safety, and tolerability of cariprazine in the treatment of acute mania in bipolar I disorder. Data sources: Three double-blind, placebo-controlled, RCTs published in English, in peer-reviewed journals, and found using Medline, Pubmed, and Cochrane Review databases. Outcomes Measured: The primary efficacy scale used in all studies was the Young Mania Rating Scale (YMRS) which is a screening tool that objectively and subjectively measures acute mania items including: irritability, speech, content, disruptive behavior, elevated mood, increased motor activity, sexual interest, sleep, language-though disorder, appearance, and insight. Safety was measured through the occurrence of one or more of the following during treatment as experienced by the patient: extrapyramidal disorder, headache, akathisia, constipation, nausea, dyspepsia, dizziness, insomnia, vomiting, diarrhea, restlessness, sedation, vision blurred, mania, pain in extremity, pyrexia, tremor, agitation, or toothache. Results: All three studies found cariprazine demonstrated efficacy and general tolerability in the treatment of mania in acute bipolar I disorder compared to placebo (p Conclusions: The results based on these three studies is the cariprazine is effective and generally well-tolerated for patients experiencing acute mania in bipolar I disorder. Future study is warranted to determine the remission rate of manic episodes after treatment with cariprazine for bipolar I disorder