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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Study Contact
- Telefonní číslo: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
|
|
Komparátor placeba: 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.
Ostatní jména:
Participants will receive placebo orally. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from DB Baseline in Clinical Global Impression-Severity (CGI-S) Score to Week 6
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 86952580MDD3001
- 2026-525307-27-00 (Identifikátor registru: EUCT number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .