A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder

NCT07747389 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: 86952580MDD30012026-525307-27-00
• Study Type: interventional
• Target: 585
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a persistent feeling of deep sadness, hopelessness, and a loss of interest in activities for a prolonged period of time and interfere with ability to function).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6

  The MADRS is a 10-item clinician-rated scale designed to measure the overall severity of depressive symptoms. The MADRS total score ranges from 0 to 60 where higher score indicates more severity in symptoms.

  DB Baseline (Day 1) up to Week 6

Secondary Outcomes (3)

• Change from DB Baseline in Clinical Global Impression-Severity (CGI-S) Score to Week 6

  DB Baseline (Day 1) up to Week 6

• Change from DB Baseline in MADRS Total Score to Week 2

  DB Baseline (Day 1) up to Week 2

• Change from DB Baseline in MADRS Total Score to Week 1

  DB Baseline (Day 1) up to Week 1

Study Arms (3)

Lumateperone: Dose 1

EXPERIMENTAL

Eligible participants will receive dose 1 of lumateperone once daily starting on Day 1 of Double-blind (DB) treatment period for up to 6 weeks. At Visit Week 6, participants who completed DB Treatment Period, may have the option to roll over into an open-label (OL) treatment period to receive dose 1 or dose 2 of lumateperone for up to 24 weeks.

Drug: Lumateperone

Lumateperone: Dose 2

EXPERIMENTAL

Eligible participants will receive dose 2 of lumateperone once daily starting on Day 1 of DB treatment period for up to 6 weeks. At Visit Week 6, participants who completed DB Treatment Period, may have the option to roll over into an OL treatment period to receive dose 1 or dose 2 of lumateperone for up to 24 weeks.

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Eligible participants will receive placebo once daily starting on Day 1 of DB treatment period for up to 6 weeks. At Visit Week 6, participants who complete the DB treatment period, may have the option to participate in OL treatment period to receive dose 1 or dose 2 of lumateperone for up to 24 weeks.

Drug: Lumateperone; Drug: Placebo

Interventions

Lumateperone DRUG

Participants will receive lumateperone orally.

Also known as: Caplyta

Lumateperone: Dose 1; Lumateperone: Dose 2; Placebo

Placebo DRUG

Participants will receive placebo orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and where applicable at DB period baseline
• Medically stable based on clinical laboratory tests performed at screening and where applicable at DB period baseline
• Meets the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for recurrent or single episode MDD, without psychotic features, based upon clinical assessment and confirmed by Structured Clinical Interview for DSM-5 Axis I Disorders - Clinical Trials Version (SCID-CT)
• Has moderate-to-severe depression as measured by a rater-administered MADRS total greater than or equal to (\>=) 26 score and corresponding to a CGI-S score of \>=4 at screening and DB baseline
• Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score of \>=15 at screening and DB baseline

You may not qualify if:

• The participant experiences a \>=25 percent (%) decrease in the MADRS total score between screening and DB baseline
• The participant experiences a \>=25% decrease in the QIDS-SR-16 total score between screening and DB baseline
• Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening period, per the investigator's clinical judgment or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past 6 months prior to the start of the screening period
• Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
• Has a history or evidence of clinically meaningful noncompliance with antidepressant therapy (ADT)s

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): September 20, 2029
• Study Completion (Estimated): September 20, 2029
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share