- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02600494
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
April 12, 2021 updated by: Intra-Cellular Therapies, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
554
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States
- Clinical Site
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Rogers, Arkansas, United States
- Clinical Site
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California
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Cerritos, California, United States
- Clinical Site
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Culver City, California, United States
- Clinical Site
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Garden Grove, California, United States
- Clinical Site
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Lemon Grove, California, United States
- Clinical Site
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National City, California, United States
- Clinical Site
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Oakland, California, United States
- Clinical Site
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Oceanside, California, United States
- Clinical Site
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Orange, California, United States
- Clinical Site
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Pico Rivera, California, United States
- Clinical Site
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Riverside, California, United States
- Clinical Site
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San Diego, California, United States
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San Marcos, California, United States
- Clinical Site
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Santa Rosa, California, United States
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Colorado
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Colorado Springs, Colorado, United States
- Clinical Site
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Florida
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Bradenton, Florida, United States
- Clinical Site
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Fort Myers, Florida, United States
- Clinical Site
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Jacksonville, Florida, United States
- Clinical Site
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Lauderhill, Florida, United States
- Clinical Site
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Miami, Florida, United States
- Clinical Site
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North Miami, Florida, United States
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Orlando, Florida, United States
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Georgia
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Atlanta, Georgia, United States
- Clinical Site
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Illinois
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Chicago, Illinois, United States
- Clinical Site
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Hoffman Estates, Illinois, United States
- Clinical Site
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Louisiana
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Lake Charles, Louisiana, United States
- Clinical Site
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Maryland
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Baltimore, Maryland, United States
- Clinical Site
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Massachusetts
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Boston, Massachusetts, United States
- Clinical Site
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Missouri
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O'Fallon, Missouri, United States
- Clinical Site
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Saint Louis, Missouri, United States
- Clinical Site
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Nevada
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Las Vegas, Nevada, United States
- Clinical Site
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New Jersey
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Berlin, New Jersey, United States
- Clinical Site
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Cherry Hill, New Jersey, United States
- Clinical Site
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Marlton, New Jersey, United States
- Clinical Site
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Toms River, New Jersey, United States
- Clinical Site
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New York
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Brooklyn, New York, United States
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Cedarhurst, New York, United States
- Clinical Site
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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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Ohio
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Cincinnati, Ohio, United States
- Clinical Site
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
- Clinical Site
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Garfield Heights, Ohio, United States
- Clinical Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Clinical Site
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Pennsylvania
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Allentown, Pennsylvania, United States
- Clinical Site
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Norristown, Pennsylvania, United States
- Clinical Site
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Philadelphia, Pennsylvania, United States
- Clinical Site
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Tennessee
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Memphis, Tennessee, United States
- Clinical Site
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Texas
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Austin, Texas, United States
- Clinical Site
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Dallas, Texas, United States
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Houston, Texas, United States
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Virginia
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Petersburg, Virginia, United States
- Clinical Site
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Washington
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Everett, Washington, United States
- Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 40 mg ITI-007 (Lumateperone)
40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
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Experimental: 60 mg ITI-007 (Lumateperone)
60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
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|
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Susan Kozauer, MD, Intra-Cellular Therapies, Inc. (ITI)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2015
Primary Completion (Actual)
January 28, 2019
Study Completion (Actual)
July 24, 2019
Study Registration Dates
First Submitted
November 5, 2015
First Submitted That Met QC Criteria
November 6, 2015
First Posted (Estimate)
November 9, 2015
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 12, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITI-007-401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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