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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Study Contact
- Numer telefonu: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
|
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Eksperymentalny: 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.
Inne nazwy:
|
|
Komparator placebo: 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.
Inne nazwy:
Participants will receive placebo orally. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from DB Baseline in Clinical Global Impression-Severity (CGI-S) Score to Week 6
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 86952580MDD3001
- 2026-525307-27-00 (Identyfikator rejestru: EUCT number)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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