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Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITI-007 (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

Major Exclusion Criteria:

  • any subject unable to provide informed consent
  • any female subject who is pregnant or breast-feeding
  • 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

40 mg ITI-007 (Lumateperone)

60 mg ITI-007 (Lumateperone)

Placebo

Arm Description

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

60 mg ITI-007 (Lumateperone) 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

Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Full Information

First Posted
November 5, 2015
Last Updated
April 12, 2021
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02600494
Brief Title
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy 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 Monotherapy 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
December 15, 2015 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
July 24, 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 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.

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
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
40 mg ITI-007 (Lumateperone)
Arm Type
Experimental
Arm Description
40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Arm Title
60 mg ITI-007 (Lumateperone)
Arm Type
Experimental
Arm Description
60 mg ITI-007 (Lumateperone) 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)
ITI-007 (Lumateperone)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame
6 weeks

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 Major Exclusion Criteria: any subject unable to provide informed consent 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. (ITI)
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Little Rock
State/Province
Arkansas
Country
United States
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Clinical Site
City
Rogers
State/Province
Arkansas
Country
United States
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Cerritos
State/Province
California
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United States
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Culver City
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California
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United States
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Garden Grove
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California
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United States
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Lemon Grove
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California
Country
United States
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City
National City
State/Province
California
Country
United States
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Oakland
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California
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United States
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Oceanside
State/Province
California
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United States
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Orange
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California
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United States
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Pico Rivera
State/Province
California
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United States
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Riverside
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California
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United States
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San Diego
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California
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United States
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San Marcos
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California
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United States
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Santa Rosa
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California
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United States
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Colorado Springs
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Colorado
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United States
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Bradenton
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Florida
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United States
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Fort Myers
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Florida
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United States
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Jacksonville
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Florida
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United States
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Lauderhill
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Florida
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United States
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Miami
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Florida
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United States
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North Miami
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United States
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Orlando
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Atlanta
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Georgia
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Chicago
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Illinois
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United States
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Hoffman Estates
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Illinois
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United States
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Lake Charles
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Louisiana
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Baltimore
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Maryland
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Boston
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Massachusetts
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United States
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O'Fallon
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Missouri
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United States
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Saint Louis
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Missouri
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Las Vegas
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Nevada
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Berlin
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New Jersey
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United States
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Cherry Hill
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New Jersey
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United States
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Marlton
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New Jersey
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United States
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Toms River
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New Jersey
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United States
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Brooklyn
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New York
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United States
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Cedarhurst
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New York
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United States
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New York
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New York
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United States
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Rochester
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New York
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United States
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Staten Island
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New York
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United States
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Cincinnati
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Ohio
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United States
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Cleveland
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Ohio
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United States
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Dayton
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Ohio
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United States
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Garfield Heights
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Ohio
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Oklahoma City
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Oklahoma
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Allentown
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Norristown
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Philadelphia
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Memphis
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Austin
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Dallas
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Houston
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Texas
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United States
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Petersburg
State/Province
Virginia
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United States
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Everett
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

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