Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
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) or Major Depressive Disorder
1 other identifier
interventional
488
5 countries
42
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate 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) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
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 Feb 2020
Typical duration for phase_3
42 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
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedResults Posted
Study results publicly available
March 19, 2025
CompletedMarch 19, 2025
March 1, 2025
2.8 years
February 24, 2020
March 4, 2025
March 4, 2025
Conditions
Keywords
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 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.
Day 43
Secondary Outcomes (1)
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
Day 43
Study Arms (2)
Lumateperone 42mg
EXPERIMENTALLumateperone 42mg administered once daily in the evening
Placebo
PLACEBO COMPARATORMatching placebo administered once daily in the evening
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects of any race, ages 18-75 inclusive
- Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
- The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
- Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
- The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
- Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
- 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
- The patient has a significant risk for suicidal behavior
- The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Clinical Site
Garden Grove, California, 92845, United States
Clinical Site
Oceanside, California, 92056, United States
Clinical Site
Sherman Oaks, California, 91403, United States
Clinical Site
Lauderhill, Florida, 33319, United States
Clinical Site
Miami, Florida, 33122, United States
Clinical Site
Orange City, Florida, 32763, United States
Clinical Site
Atlanta, Georgia, 30331, United States
Clinical Site
Decatur, Georgia, 30030, United States
Clinical Site
O'Fallon, Missouri, 63368, United States
Clinical Site
Cedarhurst, New York, 11694, United States
Clinical Site
New York, New York, 10128, United States
Clinical Site
Charlotte, North Carolina, 28211, United States
Clinical Site
Bellevue, Washington, 98007, United States
Clinical Site
Burgas, 8000, Bulgaria
Clinical Site
Kardzhali, 6600, Bulgaria
Clinical Site
Plovdiv, 4004, Bulgaria
Clinical Site
Rousse, 7003, Bulgaria
Clinical Site
Sofia, 1113, Bulgaria
Clinical Site
Sofia, 1408, Bulgaria
Clinical Site
Sofia, 1431, Bulgaria
Clinical Site
Sofia, 1680, Bulgaria
Clinical Site
Varna, 9020, Bulgaria
Clinical Site
Veliko Tarnovo, 5000, Bulgaria
Clinical Site
Vratsa, 3000, Bulgaria
Clinical Site
Moscow, 105082, Russia
Clinical Site
Saint Petersburg, 190121, Russia
Clinical Site
Saint Petersburg, 192019, Russia
Clinical Site
Saint Petersburg, 195160, Russia
Clinical Site
Saint Petersburg, 197341, Russia
Clinical Site
Saint Petersburg, 199106, Russia
Clinical Site
Tomsk, 634009, Russia
Clinical Site
Yekaterinburg, 620030, Russia
Clinical Site
Belgrade, 11000, Serbia
Clinical Site
Kovin, 26220, Serbia
Clinical Site
Kragujevac, 34000, Serbia
Clinical Site
Kyiv, 1133, Ukraine
Clinical Site
Lviv, 79021, Ukraine
Clinical site
Odesa, 65006, Ukraine
Clinical Site
Odesa, 67513, Ukraine
Clinical Site
Poltava, 36013, Ukraine
Clinical Site
Smila, 20708, Ukraine
Clinical Site
Vinnytsia, 21005, Ukraine
Related Publications (1)
Durgam S, Kozauer SG, Earley WR, Chen C, Huo J, Lakkis H, Stahl S, McIntyre RS. Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial. J Clin Psychopharmacol. 2025 Mar-Apr 01;45(2):67-75. doi: 10.1097/JCP.0000000000001964. Epub 2025 Feb 14.
PMID: 39946099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan Kozauer, MD
- 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
- No
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
February 24, 2020
First Posted
February 26, 2020
Study Start
February 27, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
March 19, 2025
Results First Posted
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share