For major depressive disorder (Adjunctive) in adultsOpen-label safety trial (Study 503) in adults

Patients on CAPLYTA sustained treatment over 6 months^1,2

9 out of 10 patients chose to continue into the open-label safety extension, and 85% stayed on CAPLYTA during the 6-month, open-label safety trial

Safety profile observed in the open-label trial was consistent with pivotal trials
Rates of TEAEs decreased over time for most events*

*Most TEAEs (>98%) were mild or moderate in severity. 46.8% of patients with TEAEs had first onset within the first 4 weeks of open-label CAPLYTA administration.

Change in depression symptom severity score over 6 months²

Swipe chart for more

MADRS total score over time^2,3

80% of patientsmet clinically defined response(reduction of MADRS total score ≥50%)

65% of patientsmet clinically defined remission(MADRS total score of ≤10)

Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability. Efficacy outcomes are exploratory and should be interpreted with caution, as the study was not powered or controlled to assess treatment efficacy.

^†Remission defined as MADRS Total Score ≤10.

ADT=antidepressant therapy; EQLTP=end of open-label treatment period; MADRS=Montgomery-Åsberg Depression Rating Scale; TEAE=treatment emergent adverse event.

Study 503 - open-label safety trial in adults⁴

Trial design

Study 503 was an open-label safety extension study of patients with MDD continuing to receive CAPLYTA 42 mg adjunctive to an antidepressant.

Eligible patients completed lead-in Study 501 or Study 502
Open-label treatment period: weekly visits through Week 4, then every 2 weeks through Week 26⁵
Primary outcome measure: safety and tolerability*
Secondary outcome measures: improvement/maintenance of depressive symptoms, measured by MADRS total score change from Study 501 or 502 baseline to Week 26 of open-label treatment

*As measured by adverse events, extrapyramidal symptoms, suicidality, and changes in laboratory parameters, vital signs, and electrocardiogram measures. Includes any adverse event that was not present before the date of the first dose in the open-label treatment period or was present but changed in severity during the open-label treatment period.

MDD=major depressive disorder.

Full graph description

This graph depicts the change in depression symptom severity score in pooled 501 and 502 studies and the open-label safety extension Study 503. Also shown is patients receiving placebo + ADT in Study 501 and Study 502 that switched to CAPLYTA in Study 503. All patients in Study 503 received CAPLYTA + ADT over 6 months.²

The right dose, right from the start

For major depressive disorder (Adjunctive) in adultsOpen-label safety trial (Study 503) in adults

Patients on CAPLYTA sustained treatment over 6 months1,2

Change in depression symptom severity score over 6 months2

View study design & full graph description

Patients on CAPLYTA sustained treatment over 6 months^1,2

Change in depression symptom severity score over 6 months²