Proven antidepressant efficacy in bipolar I and bipolar II depression as monotherapy or when added to lithium or valproate

Significant symptom relief in a broad range of adult patients with bipolar depression regardless of bipolar I or II1-3*†

Monotherapy

Adjunctive with Lithium or Valproate

This graph depicts the change from baseline in MADRS total score over 6 weeks for patients receiving CAPLYTA 42 mg or placebo as monotherapy or adjunctive therapy with lithium or valproate.
54%

improvement
from baseline1

CAPLYTA 42 mg (n=188)
Placebo (n=188)

52%

improvement
from baseline1

CAPLYTA 42 mg + lithium or valproate (n=174)
Placebo + lithium or valproate (n=174)

Monotherapy

This graph depicts the change from baseline in MADRS total score over 6 weeks for patients receiving CAPLYTA 42 mg or placebo as monotherapy
54%

improvement
from baseline1

CAPLYTA 42 mg (n=188)
Placebo (n=188)

Adjunctive with Lithium or Valproate

This graph depicts the change from baseline in MADRS total score over 6 weeks for patients receiving CAPLYTA 42 mg or placebo as adjunctive therapy with lithium or valproate.
52%

improvement
from baseline1

CAPLYTA 42 mg + lithium or valproate (n=174)
Placebo + lithium or valproate (n=174)

LSM=least squares mean; MADRS=Montgomery-Asberg Depression Rating Scale.

*Monotherapy study placebo-subtracted difference was -4.6 (95% CI, -6.3, -2.8). Mean baseline MADRS total scores for CAPLYTA 42 mg and placebo were 30.8 and 30.3, respectively. There was a 40% improvement from baseline in the placebo group. Adjunctive therapy study placebo-subtracted difference was -2.4 (95% CI, -4.4, -0.4). Mean baseline MADRS total scores for CAPLYTA 42 mg and placebo were 32.2 and 32.1, respectively. There was a 45% improvement from baseline in the placebo + lithium or valproate group.1
The MADRS total score ranges from 0 to 60. Higher scores reflect greater symptom severity.

View data on weight change

CAPLYTA separated from placebo as early as week 1 and continued to week 6 with no titration required1,2

Change in MADRS total score in monotherapy study1,2

This graph depicts the change from baseline in MADRS total score by week over a 6-week period for patients receiving CAPLYTA 42 mg or placebo as monotherapy.

  • CAPLYTA 42 mg­—the maintenance dose is the starting dose

*P=nominal. The weekly time points prior to week 6 were not powered for statistical comparison and are descriptive only.
The primary endpoint was the change from baseline to Week 6 in score on the Montgomery-Asberg Depression Rating Scale (MADRS).2 Baseline MADRS Total Score: CAPLYTA (42 mg): 30.8; placebo 30.3.1

Reduction* observed in all individual MADRS item scores in monotherapy at week 63

Limitation: These secondary endpoints were not powered for statistical comparison and are descriptive only. Therefore, the results require cautious interpretation.

This graph depicts the change in individual MADRS item scores at Week 6 for patients receiving CAPLYTA 42 mg or placebo as monotherapy.This graph depicts the change in individual MADRS item scores at Week 6 for patients receiving CAPLYTA 42 mg or placebo as monotherapy.

*LSM change from baseline on individual MADRS items scored 0-6.
Patients who were considered at risk for suicide were excluded from the clinical trials.

See key secondary endpoint data for CAPLYTA

References: 1. CAPLYTA prescribing information, 2022. 2. Calabrese JR, Durgam S, Satlin A, et al. Efficacy and safety of lumateperone for major depressive episodes associated with bipolar I or bipolar II disorder: a phase 3 randomized placebo-controlled trial. Am J Psychiatry. Published online September 23, 2021. doi:10.1176/appi.apj.2021.20091339. 3. Data on File. 2021.