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NCT Number: NCT07747389

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

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).

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumateperone

Drug

Participants will receive lumateperone orally.

Other names: Caplyta

Placebo

Drug

Participants will receive placebo orally.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    The CGI-S evaluates the severity of participant's depressive symptoms on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.

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

    Time frame: DB Baseline (Day 1) up to Week 2

    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.

  3. Change from DB Baseline in MADRS Total Score to Week 1

    Time frame: DB Baseline (Day 1) up to Week 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Registry information

Official study 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

Acronym: CANDLE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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