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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT05061719

Run by

Intra-Cellular Therapies, Inc.

People needed

812

Starts

2021-10-08

Expected to finish

2024-10-23

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In the opinion of the Investigator, patients must have safely completed the lead-in study.
• Patient is taking their ADT as prescribed from the lead-in study.

You may not qualify if…

• In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
• At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
• At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
• Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

Where it is running

• Clinical Site — Veliko Tarnovo, Bulgaria
• Clinical Site — Phoenix, Arizona, United States
• Clinical Site — Bentonville, Arkansas, United States
• Clinical Site — Little Rock, Arkansas, United States
• Clinical Site — Rogers, Arkansas, United States
• Clinical Site — Culver City, California, United States
• Clinical Site — Glendale, California, United States
• Clinical Site — Newport Beach, California, United States
• Clinical Site — Oceanside, California, United States
• Clinical Site — Redlands, California, United States
• Clinical Site — Riverside, California, United States
• Clinical Site — San Diego, California, United States
• Clinical Site — Sherman Oaks, California, United States
• Clinical Site — Temecula, California, United States
• Clinical Site — Upland, California, United States
• Clinical Site — Fort Lauderdale, Florida, United States
• Clinical Site — Jacksonville, Florida, United States
• Clinical Site — Orlando, Florida, United States
• Clinical Site — Palm Bay, Florida, United States
• Clinical Site — West Palm Beach, Florida, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Decatur, Georgia, United States
• Clinical Site — Veliko Tarnovo, Bulgaria

Full record on ClinicalTrials.gov

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