- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285515
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
March 20, 2023 updated by: Intra-Cellular Therapies, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
488
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 Contact
- Name: ITCI Clinical Trials
- Phone Number: 646 440 9333
- Email: ITCIClinicalTrials@itci-inc.com
Study Locations
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Burgas, Bulgaria, 8000
- Clinical Site
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Kardzhali, Bulgaria, 6600
- Clinical Site
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Plovdiv, Bulgaria, 4004
- Clinical Site
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Ruse, Bulgaria, 7003
- Clinical Site
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Sofia, Bulgaria, 1431
- Clinical Site
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Sofia, Bulgaria, 1113
- Clinical Site
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Sofia, Bulgaria, 1408
- Clinical Site
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Sofia, Bulgaria, 1680
- Clinical Site
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Varna, Bulgaria, 9020
- Clinical Site
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Veliko Tarnovo, Bulgaria, 5000
- Clinical Site
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Vratsa, Bulgaria, 3000
- Clinical Site
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Ekaterinburg, Russian Federation, 620030
- Clinical Site
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Moscow, Russian Federation, 105082
- Clinical Site
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Saint Petersburg, Russian Federation, 190121
- Clinical Site
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Saint Petersburg, Russian Federation, 192019
- Clinical Site
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Saint Petersburg, Russian Federation, 195160
- Clinical Site
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Saint Petersburg, Russian Federation, 197341
- Clinical Site
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Saint Petersburg, Russian Federation, 199106
- Clinical Site
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Tomsk, Russian Federation, 634009
- Clinical Site
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Belgrade, Serbia, 11000
- Clinical Site
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Kovin, Serbia, 26220
- Clinical Site
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Kragujevac, Serbia, 34000
- Clinical Site
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Kyiv, Ukraine, 1133
- Clinical Site
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Lviv, Ukraine, 79021
- Clinical Site
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Odesa, Ukraine, 65006
- Clinical Site
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Odesa, Ukraine, 67513
- Clinical Site
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Poltava, Ukraine, 36013
- Clinical Site
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Smila, Ukraine, 20708
- Clinical Site
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Vinnytsia, Ukraine, 21005
- Clinical Site
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California
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Garden Grove, California, United States, 92845
- Clinical Site
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Oceanside, California, United States, 92056
- Clinical Site
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Sherman Oaks, California, United States, 91403
- Clinical Site
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Florida
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Lauderhill, Florida, United States, 33319
- Clinical Site
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Miami, Florida, United States, 33122
- Clinical Site
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Orange City, Florida, United States, 32763
- Clinical Site
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Georgia
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Atlanta, Georgia, United States, 30331
- Clinical Site
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Decatur, Georgia, United States, 30030
- Clinical Site
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Missouri
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O'Fallon, Missouri, United States, 63368
- Clinical Site
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New York
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Cedarhurst, New York, United States, 11694
- Clinical Site
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New York, New York, United States, 10128
- Clinical Site
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North Carolina
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Charlotte, North Carolina, United States, 28211
- Clinical Site
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Washington
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Bellevue, Washington, United States, 98007
- 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
18 years to 75 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
- 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
Major Exclusion Criteria:
- 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
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: Lumateperone 42mg
Lumateperone 42mg administered once daily in the evening
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Lumateperone 42mg oral capsule
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Placebo Comparator: Placebo
Matching placebo administered once daily in the evening
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Placebo oral capsule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Åsberg Depression Rating Scale
Time Frame: Day 43
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Day 43
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impression Scale - Severity
Time Frame: Day 43
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Day 43
|
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.
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)
February 27, 2020
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
November 30, 2022
Study Registration Dates
First Submitted
February 24, 2020
First Submitted That Met QC Criteria
February 24, 2020
First Posted (Actual)
February 26, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 20, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITI-007-403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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