Study design
Efficacy data were pooled for the intention-to-treat (ITT) population and subgroup of patients with bipolar II disorder from 3 short-term, 6‑week, placebo-controlled studies2:
- Study 401 (NCT02600494) and Study 404 (NCT03249376) investigated CAPLYTA 42 mg monotherapy
- Study 402 (NCT02600507) assessed CAPLYTA 42 mg adjunctive to lithium or valproate
All trials enrolled men and women aged 18-75 years with a clinical diagnosis of bipolar I or bipolar II disorder who were experiencing a major depressive episode (MDE) defined by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥20 and Clinical Global Impression-Bipolar-Severity of Illness scale (CGI-BP-S) ≥4 at screening and baseline.2
Patients in each trial were stratified by their diagnosis of bipolar I or bipolar II disorder and randomized to placebo or CAPLYTA 42 mg administered once daily in the evening.2
- In the adjunctive study, placebo- and CAPLYTA-treated patients were also treated with lithium or valproate
Efficacy assessments included change from baseline in MADRS total score, CGI-BP-S total score, CGI-BP-S subscores (Depression, Overall Bipolar Illness, and Mania), and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) percent score.2
MADRS total score percent improvement and cumulative percent improvement were also assessed.2
Full chart description
This chart depicts the efficacy of CAPLYTA in patients with bipolar II depression versus placebo.
With the MADRS total score, patients on CAPLYTA saw a 16.4-point reduction at 6 weeks compared to 12.4-point reduction with placebo.
With the CGI-BP-S total score, patients on CAPLYTA saw a 3.4-point reduction at 6 weeks compared to a 2.4-point reduction with placebo.
With the CGI-BP-S depression score, patients on CAPLYTA saw a 1.7-point reduction at 6 weeks compared to a 1.3-point reduction with placebo.
