Clinical trial NCT05061719: An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Official title: An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Adjunctive MDD Therapy
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Detailed description: At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.

Eligibility criteria: Inclusion Criteria:

1. In the opinion of the Investigator, patients must have safely completed the lead-in study.
2. Patient is taking their ADT as prescribed from the lead-in study.

Exclusion Criteria:

1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:

   1. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
   2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
3. Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

Primary outcomes:
measure: The number and percentage of patients reporting Treatment Emergent Adverse Events
timeFrame: 26 weeks
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: 26 weeks
measure: Clinical Global Impression Scale-Severity
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Site
state: Arizona
city: Bentonville
country: United States
facility: Clinical Site
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Site
state: Arkansas
city: Rogers
country: United States
facility: Clinical Site
state: Arkansas
city: Culver City
country: United States
facility: Clinical Site
state: California
city: Glendale
country: United States
facility: Clinical Site
state: California
city: Newport Beach
country: United States
facility: Clinical Site
state: California
city: Oceanside
country: United States
facility: Clinical Site
state: California
city: Redlands
country: United States
facility: Clinical Site
state: California
city: Riverside
country: United States
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state: California
city: San Diego
country: United States
facility: Clinical Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Site
state: California
city: Temecula
country: United States
facility: Clinical Site
state: California
city: Upland
country: United States
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state: California
city: Fort Lauderdale
country: United States
facility: Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Site
state: Florida
city: Orlando
country: United States
facility: Clinical Site
state: Florida
city: Palm Bay
country: United States
facility: Clinical Site
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Joliet
country: United States
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state: Illinois
city: Overland Park
country: United States
facility: Clinical Site
state: Kansas
city: Gaithersburg
country: United States
facility: Clinical Site
state: Maryland
city: Boston
country: United States
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state: Massachusetts
city: Flowood
country: United States
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state: Mississippi
city: Saint Charles
country: United States
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state: Missouri
city: Berlin
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Brooklyn
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state: New York
city: Cedarhurst
country: United States
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state: New York
city: Mount Kisco
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Allentown
country: United States
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state: Pennsylvania
city: Media
country: United States
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state: Pennsylvania
city: Plymouth Meeting
country: United States
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state: Pennsylvania
city: Austin
country: United States
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state: Texas
city: Bellevue
country: United States
facility: Clinical Site
state: Washington
city: Burgas
country: Bulgaria
facility: Clinical Site
city: Kazanlak
country: Bulgaria
facility: Clinical Site
city: Novi Iskar
country: Bulgaria
facility: Clinical Site
city: Pleven
country: Bulgaria
facility: Clinical Site
city: Plovdiv
country: Bulgaria
facility: Clinical Site
city: Ruse
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Targovishte
country: Bulgaria
facility: Clinical Site
city: Tsarev Brod
country: Bulgaria
facility: Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Clinical Site
city: Vratsa
country: Bulgaria
facility: Clinical Site
city: Brno
country: Czechia
facility: Clinical Site
city: Brno
country: Czechia
facility: Clinical site
city: Hostivice
country: Czechia
facility: Clinical Site
city: Ostrava
country: Czechia
facility: Clinical Site
city: Plzen
country: Czechia
facility: Clinical Site
city: Prague
country: Czechia
facility: Clinical Site
city: Prague
country: Czechia
facility: Clinical Site
city: Prague
country: Czechia
facility: Clinical Site
city: Helsinki
country: Finland
facility: Clinical Site
city: Oulu
country: Finland
facility: Clinical Site
city: Bad Homburg
country: Germany
facility: Clinical Site
city: Freiburg Im Breisgau
country: Germany
facility: Clinical Site
city: Hamburg
country: Germany
facility: Clinical Site
city: Mittweida
country: Germany
facility: Clinical Site
city: Schwerin
country: Germany
facility: Clinical Site
city: Westerstede
country: Germany
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Debrecen
country: Hungary
facility: Clinical Site
city: Gyöngyös
country: Hungary
facility: Clinical Site
city: Guwahati
country: India
facility: Clinical Site
state: Assam
city: Ahmedabad
country: India
facility: Clinical Site
state: Gujarat
city: Jūnāgadh
country: India
facility: Clinical Site
state: Gujarat
city: Vadodara
country: India
facility: Clinical Site
state: Gujarat
city: Mysore
country: India
facility: Clinical Site
state: Karnataka
city: Aurangabad
country: India
facility: Clinical Site
state: Maharashtra
city: Nagpur
country: India
facility: Clinical Site
state: Maharashtra
city: Nashik
country: India
facility: Clinical Site
state: Maharashtra
city: Mumbai
country: India
facility: Clinical Site
city: Nashik
country: India
facility: Clinical Site
city: Ansan-si
country: Korea, Republic of
facility: Clinical Site
state: Chungcheongbuk-do
city: Gwangju
country: Korea, Republic of
facility: Clinical Site
city: Seoul
country: Korea, Republic of
facility: Clinical Site
city: Seoul
country: Korea, Republic of
facility: Clinical Site
city: Seoul
country: Korea, Republic of
facility: Clinical Site
city: Belchatow
country: Poland
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Bydgoszcz
country: Poland
facility: Clinical Site
city: Gdańsk
country: Poland
facility: Clinical Site
city: Gorlice
country: Poland
facility: Clinical Site
city: Leszno
country: Poland
facility: Clinical Site
city: Pruszcz Gdański
country: Poland
facility: Clinical Site
city: Toruń
country: Poland
facility: Clinical SIte
city: Wrocław
country: Poland
facility: Clinical Site
city: Bratislava
country: Slovakia
facility: Clinical Site
city: Košice
country: Slovakia
facility: Clinical Site
city: Rimavská Sobota
country: Slovakia
facility: Clinical Site
city: Svidník
country: Slovakia
facility: Clinical Site
city: Vranov Nad Topľou
country: Slovakia
facility: Clinical Site
city: Zlaté Moravce
country: Slovakia
facility: Clinical Site
city: Lund
country: Sweden
facility: Clinical Site
city: Stockholm
country: Sweden
facility: Clinical Site
Study officials:
References: