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.