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Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumateperone (ITI-007)
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

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
  • treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms

Exclusion Criteria:

  • any subject unable to provide informed consent
  • any female subject who is pregnant or breastfeeding
  • any subject judged to be medically inappropriate for study participation

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lumateperone 28 mg (ITI-007 40 mg tosylate)

Lumateperone 42 mg (ITI-007 60 mg tosylate)

Placebo

Arm Description

Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks

Placebo administered orally as visually-matched capsules once daily 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-Severity (CGI-BP-S) Depression Score
The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).

Full Information

First Posted
November 5, 2015
Last Updated
April 24, 2023
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02600507
Brief Title
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Official Title
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (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 adjunctive to lithium or valproate 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
529 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumateperone 28 mg (ITI-007 40 mg tosylate)
Arm Type
Experimental
Arm Description
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Arm Title
Lumateperone 42 mg (ITI-007 60 mg tosylate)
Arm Type
Experimental
Arm Description
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Lumateperone (ITI-007)
Intervention Type
Drug
Intervention Name(s)
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-Severity (CGI-BP-S) Depression Score
Description
The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).
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
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 treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms Exclusion Criteria: any subject unable to provide informed consent any female subject who is pregnant or breastfeeding 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
Rogers
State/Province
Arkansas
Country
United States
Facility Name
Clinical Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Culver City
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Glendale
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Lemon Grove
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Pico Rivera
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Clinical Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Santa Rosa
State/Province
California
Country
United States
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Clinical Site
City
Sherman Oaks
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Temecula
State/Province
California
Country
United States
Facility Name
Clinical Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Clinical Site
City
Lauderhill
State/Province
Florida
Country
United States
Facility Name
Clinical Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Clinical Site
City
Orange City
State/Province
Florida
Country
United States
Facility Name
Clinical Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Clinical Site
City
Savannah
State/Province
Georgia
Country
United States
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City
Chicago
State/Province
Illinois
Country
United States
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Lake Charles
State/Province
Louisiana
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United States
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Baltimore
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Maryland
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United States
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O'Fallon
State/Province
Missouri
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United States
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Saint Louis
State/Province
Missouri
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United States
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Las Vegas
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Nevada
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United States
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Berlin
State/Province
New Jersey
Country
United States
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Cherry Hill
State/Province
New Jersey
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United States
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Toms River
State/Province
New Jersey
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United States
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Cedarhurst
State/Province
New York
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United States
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New York
State/Province
New York
Country
United States
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Rochester
State/Province
New York
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United States
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Staten Island
State/Province
New York
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United States
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Charlotte
State/Province
North Carolina
Country
United States
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City
Cincinnati
State/Province
Ohio
Country
United States
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City
Dayton
State/Province
Ohio
Country
United States
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City
Garfield Heights
State/Province
Ohio
Country
United States
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City
Allentown
State/Province
Pennsylvania
Country
United States
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Philadelphia
State/Province
Pennsylvania
Country
United States
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City
The Woodlands
State/Province
Texas
Country
United States
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Clinical Site
City
Everett
State/Province
Washington
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
Pleven
Country
Bulgaria
Facility Name
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City
Plovdiv
Country
Bulgaria
Facility Name
Clinical Site
City
Ruse
Country
Bulgaria
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Clinical Site
City
Sofia
Country
Bulgaria
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Varna
Country
Bulgaria
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City
Veliko Tarnovo
Country
Bulgaria
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Vratsa
Country
Bulgaria
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Moscow
Country
Russian Federation
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Nizhny Novgorod
Country
Russian Federation
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Clinical Site
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Omsk
Country
Russian Federation
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Saint Petersburg
Country
Russian Federation
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Clinical Site
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Samara
Country
Russian Federation
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Clinical Site
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Saratov
Country
Russian Federation
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Tomsk
Country
Russian Federation
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Belgrade
Country
Serbia
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Clinical Site
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Kovin
Country
Serbia
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Novi Sad
Country
Serbia
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Clinical Site
City
Sumadija
Country
Serbia
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Clinical Site
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Clinical Site
City
Kharkiv
Country
Ukraine
Facility Name
Clinical Site
City
Kropyvnytskyi
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
Vasylkiv
Country
Ukraine
Facility Name
Clinical Site
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

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