Exploratory analysis in adults with MDDChange from baseline average score across individual MADRS items at 6 weeks1‑3*

Pooled 501 and 502 results
This graph illustrates changes from baseline in individual symptoms.

IMPROVEMENT:

Numerical improvement seen across all 10 MADRS items at Week 6

Patients were excluded from study enrollment if investigator determined they were at significant risk for suicidal behavior during participation in the study; the patient scored “yes” on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale within 6 months prior to screening or at baseline; the patient scored “yes” on Suicidal Ideation Items 4 or 5 since the screening visit; the patient had 1 or more suicide attempts within 2 years prior to screening; the patient scored ≥5 on MADRS Item 10 (Suicidal Thoughts) at screening or baseline; or the patient was considered to be in imminent danger to him/herself or others.2,3

Limitation: This pre-specified analysis was not powered to draw conclusions for individual items of MADRS.

mITT population.

*As defined by individual MADRS item scores.

ADT=antidepressant therapy; LSM=least squares mean; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; mITT=modified intention to treat; MMRM=mixed model for repeated measures.

References: 1. Data on File (REF-02960). 2. Clinical trial of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov. identifier: NCT04985942 Updated May 2, 2025. Accessed June 25, 2025. https://clinicaltrials.gov/study/NCT04985942 3. Multicenter study of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov identifier: NCT05061706 Updated May 5, 2025. Accessed July 17, 2025. https://clinicaltrials.gov/study/NCT05061706