CompletedPhase 3

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

United States812 participantsStarted 2021-10-08

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events

Timeframe: 26 weeks

Trial details

NCT IDNCT05061719

SponsorIntra-Cellular Therapies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-14

Results submitted2025-10-01

View on ClinicalTrials.gov More Major Depressive Disorder trials