For bipolar I and II depression in adultsSuperior depression symptom relief with CAPLYTA
as monotherapy at 6 weeks vs placebo¹

Change from baseline in MADRS total score at 6 weeks^1,2

This graph illustrates the LSM change from baseline for patients receiving CAPLYTA 42 mg or placebo.

CAPLYTA separated from placebo in 1 week in the pivotal monotherapy trial*

*Weekly time points prior to 6 weeks were not powered for statistical comparison and are descriptive only.²

All patients had moderate or severe depression at baseline in the monotherapy and adjunctive trials.^2,3

Secondary endpoints from pivotal monotherapy trial at 6 weeks^2†

51% response (MADRS total score ≥50% reduction) vs 37% with placebo
40% remission (MADRS total score ≤12) vs 34% with placebo

^†Limitation: These secondary endpoints were not powered for statistical comparison and are descriptive only; results require cautious interpretation.²

Reduction in depression symptoms with CAPLYTA as adjunctive therapy with lithium or valproate (-16.9 change in MADRS total score from baseline vs -14.5 with placebo; P=0.021)³

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

CAPLYTA was evaluated in two pivotal trials—both as monotherapy and adjunctive therapy¹

Studies 404 and 402 were randomized, multicenter, double-blind, placebo-controlled trials^1-3

Screening phase
Up to 2 weeks

Median age was 45 years (range: 18–72) in Study 404 and 46 years (range: 18–74) in Study 402
Patients were generally moderately to markedly ill
Met DSM-5 criteria for depressive episodes of bipolar I or II disorder

Treatment phase
6 weeks

Study 404 (N=381)

Monotherapy

Randomized 1:1

CAPLYTA
42 mg

Placebo

Study 402 (N=529)

Adjunctive

Randomized 1:1:1

CAPLYTA
28 mg or 42 mg + lithium or valproate

Placebo
+ lithium or valproate

Follow-up phase
2 weeks

SAFETY

FOLLOW-UP

Primary endpoint was
change from baseline in MADRS total score at Week 6

Primary endpoint was change from baseline in MADRS total score at Week 6

PRESPECIFIED SECONDARY ANALYSIS IN ADULTS WITH BIPOLAR I OR II DEPRESSION

Change in depression symptoms in patients with bipolar II depression as monotherapy at 6 weeks vs placebo⁴

Secondary analysis of MADRS total score over 6 weeks in adults with bipolar II depression

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

^‡Treatment difference is calculated as LSM of CAPLYTA minus LSM of placebo; all values are rounded.

MADRS is a validated rating scale used in clinical trials to support a bipolar depression indication by the FDA^1,5,6

The MADRS total score ranges from 0 to 60. Higher scores reflect greater symptom severity. Each item is rated to assess depression severity and/or monitor response to antidepressant medication.^1,7

Symptom severity score⁶

Each item on this 10-item scale is scored from 0 to 6, with 0 being the least severe and 6 being most severe

Reported Sadness
Apparent Sadness
Concentration Difficulties
Lassitude
Inability to Feel
Inner Tension (Anxiety)
Reduced Sleep
Reduced Appetite
Pessimistic Thoughts
Suicidal Thoughts

DSM=Diagnostic and Statistical Manual of Mental Disorders; LSM=least squares mean; MADRS=Montgomery-Åsberg Depression Rating Scale.

See efficacy in patients with bipolar depression and mixed features

For bipolar I and II depression in adultsSuperior depression symptom relief with CAPLYTA as monotherapy at 6 weeks vs placebo1

Change from baseline in MADRS total score at 6 weeks1,2

View study design

Secondary analysis of MADRS total score over 6 weeks in adults with bipolar II depression

View MADRS scale

For bipolar I and II depression in adultsSuperior depression symptom relief with CAPLYTA
as monotherapy at 6 weeks vs placebo¹

Change from baseline in MADRS total score at 6 weeks^1,2