Cariprazine performs well for schizophrenia, bipolar mania
AT THE NCDEU MEETING
No clinically meaningful changes occurred in lipids, liver enzymes, ECG parameters, or prolactin levels. Systolic and diastolic blood pressure each rose modestly by less than 2 mm Hg. Weight gain was minimal: a mean increase of 0.9 kg over 16 weeks, with an accompanying mean 1.0-cm increase in waist circumference.
While this was primarily a phase III safety and tolerability study, efficacy was also measured. At week 16, 63% of subjects met study criteria for disease remission as defined by a Young Mania Rating Scale (YMRS) total score of 12 or less, starting from a mean baseline YMRS score of 26.1. Most of the symptomatic improvement was attained within the first 3 weeks of treatment, with a mean 13.6-point reduction in the YMRS, modestly improved upon to a mean 15.2-point reduction by week 16.
These schizophrenia and bipolar I disorder studies were sponsored by Forest Pharmaceuticals. Dr. Kane reported serving as a consultant and/or having received honoraria for lectures from Forest and 17 other pharmaceutical companies. Dr. Ketter reported serving as a consultant to Forest and four other pharmaceutical companies as well as receiving lecture honoraria from GlaxoSmithKline and Otsuka.
