Significant improvement in disease and depression severity¹

For bipolar I and II depression in adults

CGI-BP-S total score and depression score were the key secondary endpoints in the monotherapy/adjunctive therapy (with lithium or valproate) trials at 6 weeks¹

Improvement in CGI-BP-S total score and CGI-BP-S depression score^1,2,3*^†

This graph depicts the improvement in CGI-BP-S total score and depression score at 6 weeks for patients receiving CAPLYTA 42 mg or placebo as monotherapy or adjunctive therapy with lithium or valproate.

These are well-established research rating tools measuring the clinician's overall impression of the patient.⁴

*The CGI-BP-S (Clinical Global Impression-Bipolar-Severity of Illness scale) total score is a clinician-rated scale that measures the patient's current illness state on a 21-point scale that assesses depression, mania, and overall illness, where a higher score is associated with greater illness severity. Baseline scores were 10.3 for CAPLYTA and 10.2 for placebo.¹

^†The CGI-BP-S depression score is a clinician-rated scale that measures the patient's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Baseline scores were 4.7 for CAPLYTA and 4.6 for placebo.¹

The CGI-BP-S scale measures the severity of illness on a scale of 1 to 7, 1 being Normal, Not Ill, and 7 being Very Severely Ill.

The CAPLYTA bipolar depression clinical studies evaluated severity of illness based on the CGI‑BP‑S scale. CGI‑BP‑S total score is the sum of a clinician-rated assessment score for depression + mania + overall illness.

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-Åsberg 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

Full chart description

This graph depicts the improvement in CGI-BP-S total score and CGI-BP-S depression score at 6 weeks for patients receiving CAPLYTA 42 mg or placebo as monotherapy or adjunctive therapy with lithium or valproate.

Patients on CAPLYTA in the monotherapy study saw a 3.5-point reduction at 6 weeks compared to 2.5-point reduction with placebo.
Patients on CAPLYTA in the adjunctive therapy study saw a 1.8-point reduction at 6 weeks compared to 1.5-point reduction with placebo.

See the change in quality of life, enjoyment, and satisfaction
total score with CAPLYTA

Quality of Life

Significant improvement in disease and depression severity1

For bipolar I and II depression in adults

CGI-BP-S total score and depression score were the key secondary endpoints in the monotherapy/adjunctive therapy (with lithium or valproate) trials at 6 weeks1

Improvement in CGI-BP-S total score and CGI-BP-S depression score1,2,3*†

View study design & full chart description

Significant improvement in disease and depression severity¹

CGI-BP-S total score and depression score were the key secondary endpoints in the monotherapy/adjunctive therapy (with lithium or valproate) trials at 6 weeks¹

Improvement in CGI-BP-S total score and CGI-BP-S depression score^1,2,3*^†