An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05061719
• Other study ID #: ITI-007-503
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: October 8, 2021
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 760
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Lumateperone
Lumateperone 42 mg capsules administered orally, once daily

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Burgas
Bulgaria	Clinical Site	Kazanlak
Bulgaria	Clinical Site	Novi Iskar
Bulgaria	Clinical Site	Pleven
Bulgaria	Clinical Site	Plovdiv
Bulgaria	Clinical Site	Ruse
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Targovishte
Bulgaria	Clinical Site	Tsarev Brod
Bulgaria	Clinical Site	Veliko Tarnovo
Bulgaria	Clinical Site	Veliko Tarnovo
Bulgaria	Clinical Site	Vratsa
Czechia	Clinical Site	Brno
Czechia	Clinical site	Brno
Czechia	Clinical Site	Hostivice
Czechia	Clinical Site	Ostrava
Czechia	Clinical Site	Plzen
Czechia	Clinical Site	Prague
Czechia	Clinical Site	Prague
Czechia	Clinical Site	Prague
Finland	Clinical Site	Helsinki
Finland	Clinical Site	Oulu
Germany	Clinical Site	Bad Homburg
Germany	Clinical Site	Freiburg Im Breisgau
Germany	Clinical Site	Hamburg
Germany	Clinical Site	Mittweida
Germany	Clinical Site	Schwerin
Germany	Clinical Site	Westerstede
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Budapest
Hungary	Clinical Site	Debrecen
Hungary	Clinical Site	Gyöngyös
India	Clinical Site	Ahmedabad	Gujarat
India	Clinical Site	Aurangabad	Maharashtra
India	Clinical Site	Guwahati	Assam
India	Clinical Site	Junagadh	Gujarat
India	Clinical Site	Mumbai
India	Clinical Site	Mysore	Karnataka
India	Clinical Site	Nagpur	Maharashtra
India	Clinical Site	Nashik	Maharashtra
India	Clinical Site	Nashik
India	Clinical Site	Vadodara	Gujarat
Korea, Republic of	Clinical Site	Ansan-si	Chungcheongbuk-do
Korea, Republic of	Clinical Site	Gwangju
Korea, Republic of	Clinical Site	Seoul
Korea, Republic of	Clinical Site	Seoul
Korea, Republic of	Clinical Site	Seoul
Poland	Clinical Site	Belchatow
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bialystok
Poland	Clinical Site	Bydgoszcz
Poland	Clinical Site	Gdansk
Poland	Clinical Site	Gorlice
Poland	Clinical Site	Leszno
Poland	Clinical Site	Pruszcz Gdanski
Poland	Clinical SIte	Torun
Poland	Clinical Site	Wroclaw
Slovakia	Clinical Site	Bratislava
Slovakia	Clinical Site	Košice
Slovakia	Clinical Site	Rimavská Sobota
Slovakia	Clinical Site	Svidník
Slovakia	Clinical Site	Vranov Nad Toplou
Slovakia	Clinical Site	Zlaté Moravce
Sweden	Clinical Site	Lund
Sweden	Clinical Site	Stockholm
United States	Clinical Site	Allentown	Pennsylvania
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Bellevue	Washington
United States	Clinical Site	Bentonville	Arkansas
United States	Clinical Site	Berlin	New Jersey
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Brooklyn	New York
United States	Clinical Site	Cedarhurst	New York
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Culver City	California
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Flowood	Mississippi
United States	Clinical Site	Fort Lauderdale	Florida
United States	Clinical Site	Gaithersburg	Maryland
United States	Clinical Site	Glendale	California
United States	Clinical Site	Jacksonville	Florida
United States	Clinical Site	Joliet	Illinois
United States	Clinical Site	Little Rock	Arkansas
United States	Clinical Site	Media	Pennsylvania
United States	Clinical Site	Mount Kisco	New York
United States	Clinical Site	Newport Beach	California
United States	Clinical Site	Oceanside	California
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Overland Park	Kansas
United States	Clinical Site	Palm Bay	Florida
United States	Clinical Site	Phoenix	Arizona
United States	Clinical Site	Plymouth Meeting	Pennsylvania
United States	Clinical Site	Redlands	California
United States	Clinical Site	Riverside	California
United States	Clinical Site	Rogers	Arkansas
United States	Clinical Site	Saint Charles	Missouri
United States	Clinical Site	San Diego	California
United States	Clinical Site	Sherman Oaks	California
United States	Clinical Site	Temecula	California
United States	Clinical Site	Toms River	New Jersey
United States	Clinical Site	Upland	California
United States	Clinical Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Finland,  Germany,  Hungary,  India,  Korea, Republic of,  Poland,  Slovakia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and percentage of patients reporting Treatment Emergent Adverse Events	An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.	26 weeks
Secondary	Montgomery-Åsberg Depression Rating Scale	The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.	26 weeks
Secondary	Clinical Global Impression Scale-Severity	The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).	26 weeks