Changes in weight, metabolic effects, and prolactin were similar to placebo1
Weight change was similar to placebo1
Mean change from baseline in weight at 6 weeks2
- 99% of patients receiving CAPLYTA did not experience clinically significant weight gain2*
In a 6‑month open‑label safety trial, the mean change in weight was -0.02 lbs1
All data is mean change from baseline in weight.
*Defined as ≥7% increase from baseline to 6 weeks.
Antipsychotic drugs have been reported to cause metabolic changes, including weight gain. Measure weight when initiating CAPLYTA and monitor periodically during long‑term treatment.
See Important Safety Information below to learn more.
Levels of fasting glucose, insulin, cholesterol, and triglycerides with CAPLYTA were similar to placebo at 6 weeks1,2
LDL=low-density lipoprotein.
Antipsychotic drugs have been reported to cause metabolic changes, including hyperglycemia, diabetes mellitus, and dyslipidemia. Assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
See Important Safety Information below to learn more.
Prolactin levels were similar to placebo at 6 weeks2
TEAEs=treatment-emergent adverse events.
In a 6‑month open‑label safety trial, no clinically meaningful change from baseline in prolactin levels
See Important Safety Information below to learn more.
CAPLYTA demonstrated a favorable weight, metabolic, and prolactin profile at 6 months1,2
Mean change from baseline in weight, metabolic,
and prolactin parameters in a 6‑month open‑label trial*
HDL=high-density lipoprotein; LDL=low-density lipoprotein.
*n=number of subjects with data. Baseline is defined as last non-missing pretreatment measurement.
In a 6‑month open‑label safety trial, the mean change in weight was -0.02 lbs and there was no clinically meaningful change from baseline in prolactin levels1
Short‑term study design:
Monotherapy study: 6‑week study that randomized 381 patients to either CAPLYTA 42 mg or placebo. Patients were generally moderately to markedly ill. Median age was 45 years (range 18 to 72 years). 58% were female, 91% were Caucasian, and 8% were African American.1 The primary efficacy measure was the change from baseline in Montgomery‑Asberg Depression Rating Scale (MADRS) total score.
Adjunctive therapy study: 6‑week study that randomized 529 patients to lithium or valproate with either CAPLYTA 28 mg (two‑thirds of the recommended daily dose), CAPLYTA 42 mg, or placebo. Patients were generally moderately to markedly ill. Median age was 46 years (range 18 to 75 years). 58% were female, 88% were Caucasian, and 11% were African American. The treatment effect in the CAPLYTA 28 mg group (vs placebo) was not statistically significant.1
Long‑term study design:
An open‑label study of 127 patients to determine the safety and tolerability of CAPLYTA 42 mg administered orally once daily for up to approximately 6 months in patients with bipolar depression.2
Antipsychotic drugs have been reported to cause:
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Helpful tools & resources
References: 1. CAPLYTA prescribing information. 2. Data on File. 2021.