Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
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
1 other identifier
interventional
529
5 countries
71
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Typical duration for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2020
CompletedResults Posted
Study results publicly available
May 17, 2023
CompletedMay 17, 2023
April 1, 2021
4.3 years
November 5, 2015
April 24, 2023
April 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Day 43
Secondary Outcomes (1)
Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score
Baseline to Day 43
Study Arms (3)
Lumateperone 28 mg (ITI-007 40 mg tosylate)
EXPERIMENTALLumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42 mg (ITI-007 60 mg tosylate)
EXPERIMENTALLumateperone 42 mg (ITI-007 60 mg tosylate) 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
- treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Clinical Site
Rogers, Arkansas, United States
Clinical Site
Cerritos, California, United States
Clinical Site
Costa Mesa, California, United States
Clinical Site
Culver City, California, United States
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Garden Grove, California, United States
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Glendale, California, United States
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Lemon Grove, California, United States
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Oceanside, 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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Santa Rosa, California, United States
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Sherman Oaks, California, United States
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Temecula, California, 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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Orange City, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, 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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Toms River, New Jersey, 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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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Garfield Heights, Ohio, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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The Woodlands, Texas, United States
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Everett, Washington, United States
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Burgas, Bulgaria
Clinical Site
Kardzhali, Bulgaria
Clinical Site
Lovech, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Vratsa, Bulgaria
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Moscow, Russia
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Nizhny Novgorod, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tomsk, Russia
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Belgrade, Serbia
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Kovin, Serbia
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Novi Sad, Serbia
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Šumadija, Serbia
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Ivano-Frankivsk, Ukraine
Clinical Site
Kharkiv, Ukraine
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Kropyvnytskyi, Ukraine
Clinical Site
Odesa, Ukraine
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Poltava, Ukraine
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Smila, Ukraine
Clinical Site
Vasylkiv, Ukraine
Clinical Site
Vinnytsia, Ukraine
Related Publications (1)
Suppes T, Durgam S, Kozauer SG, Chen R, Lakkis HD, Davis RE, Satlin A, Vanover KE, Mates S, McIntyre RS, Tohen M. Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023 Sep;25(6):478-488. doi: 10.1111/bdi.13310. Epub 2023 Feb 26.
PMID: 36779257DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- ITI Clinical Trials
- Organization
- Intra-Cellular Therapies, Inc.
Study Officials
- STUDY DIRECTOR
Susan Kozauer, MD
Intra-Cellular Therapies, Inc.
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
March 7, 2016
Primary Completion
July 2, 2020
Study Completion
July 2, 2020
Last Updated
May 17, 2023
Results First Posted
May 17, 2023
Record last verified: 2021-04