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

NCT ID: NCT02600494

Last Updated: 2025-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2019-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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40 mg ITI-007 (Lumateperone)

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

Group Type EXPERIMENTAL

ITI-007 (Lumateperone)

Intervention Type DRUG

60 mg ITI-007 (Lumateperone)

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

Group Type EXPERIMENTAL

ITI-007 (Lumateperone)

Intervention Type DRUG

Placebo

Placebo administered orally as visually-matched capsules once daily for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ITI-007 (Lumateperone)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Kozauer, MD

Role: STUDY_DIRECTOR

Intra-Cellular Therapies, Inc. (ITI)

Locations

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Clinical Site

Little Rock, Arkansas, United States

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Rogers, Arkansas, United States

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Cerritos, California, United States

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Culver City, California, United States

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Garden Grove, California, United States

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Lemon Grove, California, United States

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National City, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Pico Rivera, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Marcos, California, United States

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Santa Rosa, California, United States

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Colorado Springs, Colorado, United States

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Bradenton, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Lauderhill, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Lake Charles, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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O'Fallon, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Marlton, New Jersey, United States

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Toms River, New Jersey, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Garfield Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Petersburg, Virginia, United States

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Everett, Washington, United States

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Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ITI-007-401

Identifier Type: -

Identifier Source: org_study_id

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