Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension 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 (Bipolar Depression)
1 other identifier
interventional
554
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2015
Typical duration for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedStudy Start
First participant enrolled
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2019
CompletedResults Posted
Study results publicly available
November 3, 2025
CompletedNovember 3, 2025
October 1, 2025
3.1 years
November 5, 2015
March 4, 2025
October 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Day 43 in Montgomery-Ă…sberg Depression Rating Scale (MADRS) Total Score
The Montgomery-Ă…sberg 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.
6 weeks
Secondary Outcomes (1)
Time to First Sustained Response in Reduction of MADRS Total Score
6 weeks
Other Outcomes (2)
Change From Baseline to Day 175 in Montgomery-Ă…sberg Depression Rating Scale (MADRS) Total Score
Day 175
Adverse Events
Day 175
Study Arms (3)
40 mg ITI-007 (Lumateperone)
EXPERIMENTAL40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
60 mg ITI-007 (Lumateperone)
EXPERIMENTAL60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Placebo
PLACEBO COMPARATORPlacebo administered orally as visually-matched capsules once daily for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Clinical Site
Little Rock, Arkansas, United States
Clinical Site
Rogers, Arkansas, United States
Clinical Site
Cerritos, California, United States
Clinical Site
Culver City, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
National City, California, United States
Clinical Site
Oakland, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Orange, California, United States
Clinical Site
Pico Rivera, California, United States
Clinical Site
Riverside, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
San Marcos, California, United States
Clinical Site
Santa Rosa, California, United States
Clinical Site
Colorado Springs, Colorado, United States
Clinical Site
Bradenton, Florida, United States
Clinical Site
Fort Myers, Florida, United States
Clinical Site
Jacksonville, Florida, United States
Clinical Site
Lauderhill, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
North Miami, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Hoffman Estates, Illinois, United States
Clinical Site
Lake Charles, Louisiana, United States
Clinical Site
Baltimore, Maryland, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
O'Fallon, Missouri, United States
Clinical Site
St Louis, Missouri, United States
Clinical Site
Las Vegas, Nevada, United States
Clinical Site
Berlin, New Jersey, United States
Clinical Site
Cherry Hill, New Jersey, United States
Clinical Site
Marlton, New Jersey, United States
Clinical Site
Toms River, New Jersey, United States
Clinical Site
Brooklyn, New York, United States
Clinical Site
Cedarhurst, New York, United States
Clinical Site
New York, New York, United States
Clinical Site
Rochester, New York, United States
Clinical Site
Staten Island, New York, United States
Clinical Site
Cincinnati, Ohio, United States
Clinical Site
Cleveland, Ohio, United States
Clinical Site
Dayton, Ohio, United States
Clinical Site
Garfield Heights, Ohio, United States
Clinical Site
Oklahoma City, Oklahoma, United States
Clinical Site
Allentown, Pennsylvania, United States
Clinical Site
Norristown, Pennsylvania, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Memphis, Tennessee, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Petersburg, Virginia, United States
Clinical Site
Everett, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Development
- Organization
- Intra-Cellular Therapies, Inc.
Study Officials
- STUDY DIRECTOR
Susan Kozauer, MD
Intra-Cellular Therapies, Inc. (ITI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
December 15, 2015
Primary Completion
January 28, 2019
Study Completion
July 24, 2019
Last Updated
November 3, 2025
Results First Posted
November 3, 2025
Record last verified: 2025-10