A new phase III trial of the atypical antipsychotic Cariprazine has apparently shown significant results. This is now the third randomized control trial of Cariprazine, and all three have shown that Cariprazine is effective against acute mania in patients with bipolar I disorder. It is the largest study, having included 497 men and women. Aside from its size, what makes this trial different is that it tested two different dosages, 3-6 mg/day, 6-12 mg/day against placebo. The lower dosage also showed significant results. The study therefore gives a better sense of the kinds of dosages that might be effective in bipolar I patients.
Commentary
Public Domain
discussed in depth the ethical problems with the previous Cariprazine trial, and the same ethical problems arise with this one. Placebo-controlled trials in the case of Bipolar I are no longer appropriate when following the ethics code of the World Medical Association. Proven treatments for acute psychosis in bipolar I patients exist, and the risk of a manic episode is a risk of serious harm. This trial took all members off of their medications for four to seven days, and then 161 bipolar I people were put on placebo as a part of the trial itself. The comparison in these trials should be to proven treatments that already exist, not to placebo. Unfortunately, the FDA continues to insist on placebo-controlled trials like this one.
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