Most antipsychotics are approved to treat bipolar manic or mixed episodes, but currently only lurasidone and quetiapine are approved for bipolar depression (lurasidone has not been assessed in bipolar mania and is not indicated for its treatment). Cariprazine (trade name Vraylar) was recently approved by the FDA for the acute treatment of manic or mixed episodes associated with bipolar I disorder, so if these results hold up in a larger clinical study, it could provide patients with another comprehensive medication for bipolar disorder.
In this trial, 571 participants were randomized to receive daily doses of placebo or cariprazine at 0.75 mg, 1.5 mg, or 3.0 mg for eight weeks. While there was no difference in the reduction of MADRS (Montgomery–Åsberg Depression Rating Scale) total score between the group that received cariprazine at 0.75 mg/day and the group that received placebo, the group administered cariprazine at 1.5 mg/day showed significantly greater improvement on MADRS total score change (4 points lower) after 6 weeks. The group that received cariprazine at 3.0 mg/day also showed some improvements, but these results were not statistically significant.
Cariprazine was generally well tolerated over the course of treatment. The most common adverse events in cariprazine-treated patients were akathisia and insomnia; weight gain was slightly higher with cariprazine than with placebo.
“Of the cariprazine dosages studied, 1.5 mg/day demonstrated the most robust efficacy and good safety, suggesting that it may be an effective dosage for the treatment of bipolar I depression,” the study authors wrote. “Given the limited number of positive studies for atypical antipsychotics in bipolar I depression, future studies are warranted to extend these phase II findings.”
For related information, see the Psychiatric News articles “Cariprazine Joins Growing Group of Approved Antipsychotics” and “As FDA Decision Nears, Cariprazine Collects More Proof of Efficacy.”