A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder (CANDLE)
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
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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Study Contact
- Telefonnummer: 844-434-4210
- E-Mail: Participate-In-This-Study1@its.jnj.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Lumateperone: Dose 1
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. |
Participants will receive lumateperone orally.
Andere Namen:
|
|
Experimental: Lumateperone: Dose 2
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. |
Participants will receive lumateperone orally.
Andere Namen:
|
|
Placebo-Komparator: Placebo
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. |
Participants will receive lumateperone orally.
Andere Namen:
Participants will receive placebo orally. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6
Zeitfenster: 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. |
DB Baseline (Day 1) up to Week 6
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from DB Baseline in Clinical Global Impression-Severity (CGI-S) Score to Week 6
Zeitfenster: 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. |
DB Baseline (Day 1) up to Week 6
|
|
Change from DB Baseline in MADRS Total Score to Week 2
Zeitfenster: 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. |
DB Baseline (Day 1) up to Week 2
|
|
Change from DB Baseline in MADRS Total Score to Week 1
Zeitfenster: 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. |
DB Baseline (Day 1) up to Week 1
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 86952580MDD3001
- 2026-525307-27-00 (Registrierungskennung: EUCT number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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