Magazine article Clinical Psychiatry News

Cariprazine Performs Well for Mania in 16-Week Trial

Magazine article Clinical Psychiatry News

Cariprazine Performs Well for Mania in 16-Week Trial

Article excerpt


HOLLYWOOD, FLA.--The novel oral antipsychotic agent cariprazine showed efficacy for treating bipolar I, Dr. Terence A. Ketter reported at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Dr. Ketter presented a phase III, open-label, 16-week, study of flexibly dosed cariprazine in 402 patients with bipolar I disorder.

Dosing of cariprazine was permitted at 3-12 mg/day. The actual mean dose used in the study was 6.2 mg/day. The primary study endpoints involved safety and tolerability, since the drug already had shown efficacy in three separate 3-week-long studies in acute mania.

This 16-week study was undertaken in recognition that the real challenge in bipolar I disorder is long-term management. Nearly half of all patients who respond to initial conventional therapies relapse within 2 years, mainly because of high rates of nonadherence, explained Dr. Ketter, professor of psychiatry and behavioral sciences and chief of the bipolar disorders clinic at Stanford (Calif.) University.

Just 33% of participants completed the 16-week study. Sixteen percent of subjects withdrew because of adverse events, roughly the same number as for protocol violations.

The major tolerability issue in the phase III trial was treatment-emergent akathisia, which occurred in 37% of participants. In addition, 7% experienced treatment-emergent extrapyramidal symptoms as defined by a Simpson-Angus Scale score of 3 or less at baseline rising to greater than 3 on treatment. …

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