NCT05061719

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 812 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Detailed description

At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone 42 mg capsules administered orally, once daily

Timeline

• Start date: 2021-10-08
• Primary completion: 2024-10-14
• Completion: 2024-10-23
• First posted: 2021-09-29
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

109 sites across 11 countries: United States, Bulgaria, Czechia, Finland, Germany, Hungary, India, Poland, Slovakia, South Korea, Sweden

Regulatory

• FDA-regulated drug study