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Not yet recruiting NCT07747389

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

Phase III Interventional Depressive Disorder, Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumateperone, Placebo.
Who it may be relevant to
Registry conditions: Depressive Disorder, Major. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone

Overview

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).

Interventions

  • Drug Lumateperone
    Participants will receive lumateperone orally.
  • Drug Placebo
    Participants will receive placebo orally.

Primary outcome measures

  • Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6 [Time frame: DB Baseline (Day 1) up to Week 6]
Secondary outcome measures (3)
  • Change from DB Baseline in Clinical Global Impression-Severity (CGI-S) Score to Week 6 [Time frame: DB Baseline (Day 1) up to Week 6]
  • Change from DB Baseline in MADRS Total Score to Week 2 [Time frame: DB Baseline (Day 1) up to Week 2]
  • Change from DB Baseline in MADRS Total Score to Week 1 [Time frame: DB Baseline (Day 1) up to Week 1]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07747389 · 86952580MDD3001 · 2026-525307-27-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗