For major depressive disorder (Adjunctive) in adultsWeight and metabolic effects
Change in weight and metabolic impact1-3
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| Pooled safety data from 6-week trials (Study 501 and 502) and a 6-month, open-label safety trial (Study 503)* | |||
|---|---|---|---|
| 6-WEEK TRIALS | 6‑MONTH, OPEN‑LABEL SAFETY TRIAL† | ||
| Body weight and BMI | CAPLYTA + ADT (n=483) | ADT alone (n=481) | CAPLYTA + ADT (n=809) |
| Weight mean change from baseline, lbs (kg) | -0.13 (-0.06) | 0.09 (0.04) | -0.35 (-0.16) |
| BMI mean change from baseline (kg/m2) | -0.02 | 0.02 | 0.0 |
| Metabolic profile (mean change from baseline, mg/dL) | |||
| Total cholesterol | -9.8 | -2.3 | -8.2 |
| LDL cholesterol | -9.4 | -2.0 | -9.6 |
| HDL cholesterol | -0.6 | -0.6 | 0.1 |
| Triglycerides | -3.4 | 3.6 | -0.2 |
| Glucose | 0.1 | 0.7 | 1.1 |
| Insulin (μIU/L) | -1.39 | 0.81 | -0.4 |
| Hemoglobin A1c (%) | -0.03 | 0.01 | 0.0 |
| Prolactin mean change from baseline (ng/mL) | 1.11 | 0.99 | 1.1 |
| Pooled safety data from 6-week trials (Study 501 and 502) and a 6-month, open-label safety trial (Study 503)* | |||
|---|---|---|---|
| 6-WEEK TRIALS | 6‑MONTH, OPEN‑LABEL SAFETY TRIAL† | ||
| Body weight and BMI | CAPLYTA + ADT (n=483) | ADT alone (n=481) | CAPLYTA + ADT (n=809) |
| Weight mean change from baseline, lbs (kg) | -0.13 (-0.06) | 0.09 (0.04) | -0.35 (-0.16) |
| BMI mean change from baseline (kg/m2) | -0.02 | 0.02 | 0.0 |
| Metabolic profile (mean change from baseline, mg/dL) | |||
| Total cholesterol | -9.8 | -2.3 | -8.2 |
| LDL cholesterol | -9.4 | -2.0 | -9.6 |
| HDL cholesterol | -0.6 | -0.6 | 0.1 |
| Triglycerides | -3.4 | 3.6 | -0.2 |
| Glucose | 0.1 | 0.7 | 1.1 |
| Insulin (μIU/L) | -1.39 | 0.81 | -0.4 |
| Hemoglobin A1c (%) | -0.03 | 0.01 | 0.0 |
| Prolactin mean change from baseline (ng/mL) | 1.11 | 0.99 | 1.1 |
The proportion of patients with an increase in weight ≥7% from baseline to the end of the 6-week studies between CAPLYTA-treated and placebo-treated patients was similar.
†Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability.
*Number of patients with available data varies for each measurement; based on assessments of patients with a baseline and a last, non-missing value.
On average, patients did not experience weight gain (-0.13 lbs or -0.06 kg CAPLYTA + ADT, 0.09 lbs or 0.04 kg placebo + ADT) or metabolic impact
at 6 weeks1,2‡
WARNINGS & PRECAUTIONS: 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.
Please see additional Important Safety Information, including Boxed WARNINGS, below.
‡Metabolic parameters included triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, glucose, hemoglobin A1c, insulin, and prolactin.2
ADT=antidepressant therapy; BMI=body mass index; HDL=high-density lipoprotein; LDL=low-density lipoprotein.
