Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
1 other identifier
interventional
381
6 countries
47
Brief Summary
The study will evaluate the efficacy and safety of ITI-007 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 P50-P75 for phase_3
Started Nov 2017
Shorter than P25 for phase_3
47 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
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
June 3, 2022
CompletedJune 3, 2022
May 1, 2022
1.3 years
August 11, 2017
April 20, 2022
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline 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.
Baseline to Day 43
Secondary Outcomes (2)
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
Baseline to Day 43
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
Baseline to Day 43
Study Arms (2)
Lumateperone
EXPERIMENTALLumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks
Placebo
PLACEBO COMPARATORPlacebo administered once daily every evening 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
- able to provide written informed consent
You may not qualify if:
- 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 (47)
Clinical Site
Birmingham, Alabama, 35294, United States
Clinical Site
Sherman Oaks, California, 91403, United States
Clinical Site
Miami, Florida, 33133, United States
Clinical Site
Orange City, Florida, 32763, United States
Clinical Site
Atlanta, Georgia, 30322, United States
Clinical Site
Decatur, Georgia, 30030, United States
Clinical Site
Chicago, Illinois, 60612, United States
Clinical Site
Joliet, Illinois, 60435, United States
Clinical Site
Shreveport, Louisiana, 71101, United States
Clinical Site
St Louis, Missouri, 63128, United States
Clinical Site
Buffalo, New York, 14215, United States
Clinical Site
Charlotte, North Carolina, 28211, United States
Clinical Site
The Woodlands, Texas, 77381, United States
Clinical Site
Bothell, Washington, 98011, United States
Clinical Site
Burgas, Bulgaria
Clinical Site
Kardzhali, Bulgaria
Clinical Site
Lovech, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Rousse, Bulgaria
Clinical Site
Sofia, Bulgaria
Clinical Site
Targovishte, Bulgaria
Clinical Site
Tsarev Brod, Bulgaria
Clinical Site
Varna, Bulgaria
Clinical Site
Veliko Tarnovo, Bulgaria
Clinical Site
Barranquilla, Colombia
Clinical Site
Bello, Colombia
Clinical Site
Pereira, Colombia
Clinical Site
Moscow, Russia
Clinical Site
Nizhny Novgorod, Russia
Clinical Site
Omsk, Russia
Clinical Site
Saint Petersburg, Russia
Clinical Site
Samara, Russia
Clinical Site
Saratov, Russia
Clinical Site
Tomsk, Russia
Clinical Site
Yekaterinburg, Russia
Clinical Site
Belgrade, Serbia
Clinical Site
Kragujevac, Serbia
Clinical Site
Novi Sad, Serbia
Clinical Site
Ivano-Frankivsk, Ukraine
Clinical Site
Kharkiv, Ukraine
Clinical Site
Kherson, Ukraine
Clinical Site
Lviv, Ukraine
Clinical Site
Odesa, Ukraine
Clinical Site
Poltava, Ukraine
Clinical Site
Smila, Ukraine
Clinical Site
Uzhhorod, Ukraine
Clinical Site
Vinnytsia, Ukraine
Related Publications (2)
McIntyre RS, Durgam S, Huo J, Kozauer SG, Stahl SM. The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. J Clin Psychiatry. 2023 Apr 24;84(3):22m14739. doi: 10.4088/JCP.22m14739.
PMID: 37103915DERIVEDCalabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23.
PMID: 34551584DERIVED
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
August 11, 2017
First Posted
August 15, 2017
Study Start
November 27, 2017
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
June 3, 2022
Results First Posted
June 3, 2022
Record last verified: 2022-05