Significant improvement in disease and depression severity at 6 weeks in adults with bipolar I and bipolar II depression1
CGI-BP-S total score was the key secondary endpoint in the monotherapy trial1,2*
CAPLYTA 42 mg (n=188)
Placebo (n=188)
CGI-BP-S depression score was the key secondary endpoint in the adjunctive therapy trial (with lithium or valproate)3†
CAPLYTA 42 mg (n=188)
Placebo (n=188)
These are well-established research rating tools measuring the clinician's overall clinical 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.1,3
†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.1,3
CGI-BP-S scale description
Severity of illness |
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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-Asberg 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 depression total score at Week 6 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 Week 6 compared to 2.5-point reduction with placebo. Patients on CAPLYTA in the adjunctive therapy study saw a 1.8-point reduction at Week 6 compared to 1.5-point reduction with placebo.
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Helpful tools & resources
References: 1. CAPLYTA prescribing information. 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. 4. Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgemont). 2007;4(7):28-37.