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Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Primary Purpose

Bipolar Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumateperone
Placebos
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 focused on measuring Mixed Features

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
  • Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
  • The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
  • Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
  • The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
  • Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
  • 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
  • The patient has a significant risk for suicidal behavior
  • The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lumateperone 42mg

Placebo

Arm Description

Lumateperone 42mg administered once daily in the evening

Matching placebo administered once daily in the evening

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale

Secondary Outcome Measures

Clinical Global Impression Scale - Severity

Full Information

First Posted
February 24, 2020
Last Updated
March 20, 2023
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04285515
Brief Title
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
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) or Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (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
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate 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) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression, Major Depressive Disorder
Keywords
Mixed Features

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lumateperone 42mg
Arm Type
Experimental
Arm Description
Lumateperone 42mg administered once daily in the evening
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo administered once daily in the evening
Intervention Type
Drug
Intervention Name(s)
Lumateperone
Intervention Description
Lumateperone 42mg oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo oral capsule
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scale - Severity
Time Frame
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 Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1) Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2) The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning 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 The patient has a significant risk for suicidal behavior The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma
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
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Clinical Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
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
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
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
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
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Clinical Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11694
Country
United States
Facility Name
Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10128
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
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Clinical Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Clinical Site
City
Kardzhali
ZIP/Postal Code
6600
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
1113
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Clinical Site
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Clinical Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Clinical Site
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Clinical Site
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Clinical Site
City
Moscow
ZIP/Postal Code
105082
Country
Russian Federation
Facility Name
Clinical Site
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Clinical Site
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Clinical Site
City
Saint Petersburg
ZIP/Postal Code
195160
Country
Russian Federation
Facility Name
Clinical Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Clinical Site
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Clinical Site
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Clinical Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Site
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Facility Name
Clinical Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Site
City
Kyiv
ZIP/Postal Code
1133
Country
Ukraine
Facility Name
Clinical Site
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Clinical site
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Clinical Site
City
Odesa
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Clinical Site
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Facility Name
Clinical Site
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
Clinical Site
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

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