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Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Primary Purpose

Bipolar Depression

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

About this trial

This is an interventional treatment trial for Bipolar Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  • male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
  • experiencing a current major depressive episode
  • able to provide written informed consent

Major Exclusion Criteria:

  • any female subject who is pregnant or breast-feeding
  • any subject judged to be medically inappropriate for study participation

Sites / Locations

  • Clinical Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lumateperone

Placebo

Arm Description

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks

Placebo administered once daily every evening for 6 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The Montgomery-Åsberg Depression Rating Scale (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.

Secondary Outcome Measures

Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.

Full Information

First Posted
August 11, 2017
Last Updated
May 10, 2022
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03249376
Brief Title
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

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
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumateperone
Arm Type
Experimental
Arm Description
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered once daily every evening for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Lumateperone
Other Intervention Name(s)
ITI-007
Intervention Description
Lumateperone 42 mg (ITI-007 60 mg tosylate)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Description
The Montgomery-Åsberg Depression Rating Scale (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
Baseline to Day 43
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
Description
The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
Time Frame
Baseline to Day 43
Title
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
Description
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.
Time Frame
Baseline to Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria: male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder experiencing a current major depressive episode able to provide written informed consent Major Exclusion Criteria: any female subject who is pregnant or breast-feeding any subject judged to be medically inappropriate for study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Kozauer, MD
Organizational Affiliation
Intra-Cellular Therapies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
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
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Clinical Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Clinical Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Clinical Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Clinical Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Clinical Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
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
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Clinical Site
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Clinical Site
City
Burgas
Country
Bulgaria
Facility Name
Clinical Site
City
Kardzhali
Country
Bulgaria
Facility Name
Clinical Site
City
Lovech
Country
Bulgaria
Facility Name
Clinical Site
City
Plovdiv
Country
Bulgaria
Facility Name
Clinical Site
City
Ruse
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
Country
Bulgaria
Facility Name
Clinical Site
City
Targovishte
Country
Bulgaria
Facility Name
Clinical Site
City
Tsarev Brod
Country
Bulgaria
Facility Name
Clinical Site
City
Varna
Country
Bulgaria
Facility Name
Clinical Site
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Clinical Site
City
Barranquilla
Country
Colombia
Facility Name
Clinical Site
City
Bello
Country
Colombia
Facility Name
Clinical Site
City
Pereira
Country
Colombia
Facility Name
Clinical Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Clinical Site
City
Moscow
Country
Russian Federation
Facility Name
Clinical Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Clinical Site
City
Omsk
Country
Russian Federation
Facility Name
Clinical Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Clinical Site
City
Samara
Country
Russian Federation
Facility Name
Clinical Site
City
Saratov
Country
Russian Federation
Facility Name
Clinical Site
City
Tomsk
Country
Russian Federation
Facility Name
Clinical Site
City
Belgrade
Country
Serbia
Facility Name
Clinical Site
City
Kragujevac
Country
Serbia
Facility Name
Clinical Site
City
Novi Sad
Country
Serbia
Facility Name
Clinical Site
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Clinical Site
City
Kharkiv
Country
Ukraine
Facility Name
Clinical Site
City
Kherson
Country
Ukraine
Facility Name
Clinical Site
City
Lviv
Country
Ukraine
Facility Name
Clinical Site
City
Odesa
Country
Ukraine
Facility Name
Clinical Site
City
Poltava
Country
Ukraine
Facility Name
Clinical Site
City
Smila
Country
Ukraine
Facility Name
Clinical Site
City
Uzhgorod
Country
Ukraine
Facility Name
Clinical Site
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34551584
Citation
Calabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23.
Results Reference
derived

Learn more about this trial

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

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