In an additional study of adults with bipolar I or II depression,Observed change in depression symptoms in patients with mixed features, with or without symptoms of anxiety^*, vs placebo^1,2

Primary endpoint

MADRS total score from baseline
at 6 weeks in bipolar depression patients exhibiting mixed features

change in depressive symptoms in patients with mixed features on CAPLYTA vs 12 points with placebo at 6 weeks^1,3†

POST HOC analysis

MADRS total score in patients
with mixed features and symptoms of anxiety^2‡

^‡Limitation: These post hoc analyses were not powered for statistical comparison and are descriptive only. Results require cautious interpretation. This study was not designed to assess the effect of CAPLYTA on symptoms of mania or anxiety.^2*

*CAPLYTA is not approved to treat mania or anxiety. Symptoms of anxiety in patients with bipolar depression were based on the DSM-5 criteria for anxious distress.^2,4

^†In patients with bipolar depression with mixed features, the placebo-subtracted difference was -5.7 for MADRS total score (95% CI: -8.3, -3.1). Mean baseline MADRS total scores for CAPLYTA 42 mg and placebo were 31.8 and 31.1 respectively.¹

^§Treatment difference is calculated as LSM of CAPLYTA minus LSM of placebo; all values are rounded.²

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

Study 403–Prespecified subgroup analysis and additional post hoc analysis in adults^1,2

Randomized, double-blind, placebo-controlled, multicenter trial (Study 403) that evaluated the efficacy and safety of CAPLYTA (monotherapy) vs placebo to treat depressive episodes in patients also exhibiting mixed features (N=388).

202 patients enrolled in the study had a diagnosis of bipolar I or II depression with mixed features

Key inclusion criteria

Adult patients, aged 18 to 75 years, who met DSM-5 criteria for bipolar depression with mixed features with a YMRS score between 4 and 16 were included. Mean age was 42 years. 64% were female, 83% were White, and 17% were Black. Patients must have a MADRS total score of ≥24 and CGI-S total score of ≥4.

mITT population

CAPLYTA 42 mg (n=100)

Placebo (n=99)

Primary endpoint:

change in MADRS total score from baseline at 6 weeks

A post hoc analysis of Study 403 evaluated patients with bipolar depression, mixed features, and anxious distress at baseline (n=108).

Of the prespecified bipolar depression with mixed features population, 54% or 108 patients also exhibited anxious distress at baseline
The post hoc analysis evaluated change in MADRS total score in patients at Week 6

Mixed features & anxious distress criteria

As defined by the DSM-5, mixed features is defined by the presence of at least 3 of the following subsyndromal manic/hypomanic symptoms during most days of a depressive episode¹:

Elevated mood
Inflated self-esteem
Increased talkativeness
Racing thoughts
Increased risky behavior
Increased energy or goal-directed activity
Decreased need for sleep

As defined by the DSM-5, anxious distress is defined by the presence of ≥2 of the following symptoms during a depressive episode⁵:

Feeling keyed up
Feeling unusually restless
Difficulty concentrating because of worry
Fear that something bad may happen
Feeling loss of control

CGI-S=Clinical Global Impression-Severity; DSM=Diagnostic and Statistical Manual of Mental Disorders; MADRS=Montgomery-Åsberg Depression Rating Scale; YMRS=Young Mania Rating Scale.

See the well-established safety and tolerability profile for CAPLYTA

In an additional study of adults with bipolar I or II depression,Observed change in depression symptoms in patients with mixed features, with or without symptoms of anxiety*, vs placebo1,2

Primary endpoint

MADRS total score from baseline at 6 weeks in bipolar depression patients exhibiting mixed features

POST HOC analysis

MADRS total score in patients with mixed features and symptoms of anxiety2‡

View study design

Study 403–Prespecified subgroup analysis and additional post hoc analysis in adults1,2