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

Primary Purpose

Major Depressive Disorder

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumateperone
Sponsored by
Intra-Cellular Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Adjunctive MDD Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumateperone 42 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
September 20, 2021
Last Updated
July 28, 2023
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05061719
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Adjunctive MDD Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumateperone 42 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lumateperone
Intervention Description
Lumateperone 42 mg capsules administered orally, once daily
Primary Outcome Measure Information:
Title
The number and percentage of patients reporting Treatment Emergent Adverse Events
Description
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale
Description
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.
Time Frame
26 weeks
Title
Clinical Global Impression Scale-Severity
Description
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).
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In the opinion of the Investigator, patients must have safely completed the lead-in study. Patient is taking their ADT as prescribed from the lead-in study. Exclusion Criteria: In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study. 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: At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version; At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts). 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.
Facility Information:
Facility Name
Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Clinical Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Clinical Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Clinical Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Clinical Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Clinical Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Clinical Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Clinical Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Clinical Site
City
Temecula
State/Province
California
ZIP/Postal Code
92951
Country
United States
Facility Name
Clinical Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Clinical Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Site
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32905
Country
United States
Facility Name
Clinical Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Clinical Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Clinical Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Clinical Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Clinical Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Clinical Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Clinical Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Clinical Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Clinical Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Clinical Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Clinical Site
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Clinical Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Clinical Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Clinical Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Clinical Site
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Clinical Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Clinical Site
City
Burgas
ZIP/Postal Code
8001
Country
Bulgaria
Facility Name
Clinical Site
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Clinical Site
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Facility Name
Clinical Site
City
Pleven
ZIP/Postal Code
5809
Country
Bulgaria
Facility Name
Clinical Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Clinical Site
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Clinical Site
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Clinical Site
City
Tsarev Brod
ZIP/Postal Code
9747
Country
Bulgaria
Facility Name
Clinical Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Clinical Site
City
Veliko Tarnovo
ZIP/Postal Code
5047
Country
Bulgaria
Facility Name
Clinical Site
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
Clinical Site
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
Clinical site
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Clinical Site
City
Hostivice
ZIP/Postal Code
253 01
Country
Czechia
Facility Name
Clinical Site
City
Ostrava
ZIP/Postal Code
708 00
Country
Czechia
Facility Name
Clinical Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Clinical Site
City
Prague
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Clinical Site
City
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Clinical Site
City
Prague
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Clinical Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Clinical Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Clinical Site
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Clinical Site
City
Freiburg Im Breisgau
ZIP/Postal Code
79104
Country
Germany
Facility Name
Clinical Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Clinical Site
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Clinical Site
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Clinical Site
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Clinical Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Clinical Site
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Clinical Site
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781010
Country
India
Facility Name
Clinical Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Clinical Site
City
Jūnāgadh
State/Province
Gujarat
ZIP/Postal Code
362001
Country
India
Facility Name
Clinical Site
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Facility Name
Clinical Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Clinical Site
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Clinical Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Clinical Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422001
Country
India
Facility Name
Clinical Site
City
Mumbai
ZIP/Postal Code
400008
Country
India
Facility Name
Clinical Site
City
Nashik
ZIP/Postal Code
422005
Country
India
Facility Name
Clinical Site
City
Ansan-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Clinical Site
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Clinical Site
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Clinical Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Clinical Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Clinical Site
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-464
Country
Poland
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Clinical Site
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
Clinical Site
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Clinical Site
City
Gorlice
ZIP/Postal Code
38-300
Country
Poland
Facility Name
Clinical Site
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Clinical Site
City
Pruszcz Gdański
ZIP/Postal Code
83-000
Country
Poland
Facility Name
Clinical SIte
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Clinical Site
City
Wrocław
ZIP/Postal Code
50-414
Country
Poland
Facility Name
Clinical Site
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
Clinical Site
City
Košice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Clinical Site
City
Rimavská Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Clinical Site
City
Svidník
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Clinical Site
City
Vranov Nad Topľou
ZIP/Postal Code
09301
Country
Slovakia
Facility Name
Clinical Site
City
Zlaté Moravce
ZIP/Postal Code
953 01
Country
Slovakia
Facility Name
Clinical Site
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Facility Name
Clinical Site
City
Stockholm
ZIP/Postal Code
11329
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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