Bipolar Today

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A new phase-three research trial has provided positive results for the newly-developed antipsychotic Cariprazine and its use for the treatment of mania in bipolar disorder 1. In a study of 312 people, Cariprazine showed that it was significantly more effective than placebo. In addition, the drug seemed to be well tolerated. 32 percent of people discontinued its use when compared to 31 percent for placebo, and 10 percent discontinued due to “adverse events” as opposed to 7 percent for placebo. As a result, it looks like a new atypical antipsychotic will soon be available on the market. Full coverage of the study can be found here.

Commentary

That a new atypical psychotic is effective isn’t the most important news; there are already several available effective ones on the market. This study doesn’t even look at their relative effectiveness. What makes these results impressive is the level of toleration for the medication. Half the battle of producing medications is producing medications that have few side effects, so this one may be a real benefit, especially with less and less medications currently being developed.

However, there was something worrisome about this trial. Doing a placebo-controlled phase-3 trial is uncommon (phase-2 trials are initial trials for efficacy, while phase 3 trials are larger trials for efficacy). In order to run this study, 156 people with bipolar 1 were off of their medication for the duration of the trial, and manic episodes are degenerative. I understand that the FDA requires placebo-based trials for approval (Cariprazine currently is only used off-label for bipolar), but such trials should be restricted as much as is possible. That may not have been done in this case, and the sheer size of this placebo-controlled trial is worrisome. It shows perhaps that either Gedeon Richter was too anxious to get the drug approved, the FDA is being too demanding for placebo-based trials in the case of known degenerative illnesses or the IRB that approved this is being too lax (or some combination of the three).

Related posts:

1. Phase III Cariprazine Trial Shows Positive Results
2. The FDA Versus the WMA: Why the Recent Cariprazine Trial Was Unethical
3. “Brain Pacemaker” Shows Promise
4. Mindfulness-Based Cognitive Therapy Shows Promise: Study
5. Transcranial Magnetic Stimulation Receives FDA Approval for Trial