Objectives: To evaluate the effect of short-term treatment with lurasidone on weight and metabolic parameters in patients with bipolar I depression.
Methods: Safety results were analyzed from two 6-week, double-blind, placebo-controlled studies that evaluated the efficacy and safety of lurasidone as monotherapy (20-60 mg/d and 80-120 mg/d) or as adjunctive therapy (20-120 mg/d) with lithium (Li) or valproate (VPA), in patients with bipolar I depression, with or without rapid cycling (DSM-IV-TR).
Results: In the monotherapy study, the proportion of subjects with a clinically significant (≥7%) increase in weight from baseline to Week 6 was low for lurasidone (2.4%) and placebo (0.7%). Comparable median changes were observed at Week 6 in total cholesterol (-0.5 vs. -3.0 mg/dL), LDL cholesterol (-2.0 vs. -2.0 mg/dL), triglycerides (+1.5 vs. +8.0 mg/dL) and glucose (0.0 vs. +0.5 mg/dL) with lurasidone and placebo, respectively. No dose-related effects on metabolic parameters were observed. In the adjunctive therapy study, the proportion of subjects with a clinically significant increase in weight was low for lurasidone (3.1%) and placebo (0.7%). Comparable median changes were observed at Week 6 in total cholesterol (-4.0 vs. 0.0 mg/dL), LDL cholesterol (-3.0 vs. -3.0 mg/dL), triglycerides (+4.5 vs. -4.0 mg/dL) and glucose (+1.0 vs. +1.0 mg/dL) with lurasidone and placebo, respectively.
Conclusions: In these two placebo-controlled studies in subjects with bipolar I depression, short-term treatment with lurasidone, either as monotherapy, or as adjunctive therapy with Li or VPA, was associated with minimal changes in weight, lipid parameters, or measures of glycemic control.