Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, MBA, PhD, PA-C
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<0.05). The YMRS baseline scores compared to week 3 after treatment with carpirazine low dose (3 mg/day) and high dose (12 mg/day) were significantly lower than the placebo group (p<0.05) in all three studies. According to all three studies the most common treatment related adverse events were: akathisia, extrapyramidal symptoms, nausea, and constipation.
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.
Reaume, Evan A., "Is Cariprazine Effective and Safe in Treating Acute Mania in Bipolar I Disorder?" (2016). PCOM Physician Assistant Studies Student Scholarship. 422.