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Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04285515
Recruitment Status : Completed
First Posted : February 26, 2020
Last Update Posted : March 22, 2023
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Major Depressive Disorder Drug: Lumateperone Drug: Placebos Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 27, 2020
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lumateperone 42mg
Lumateperone 42mg administered once daily in the evening
Drug: Lumateperone
Lumateperone 42mg oral capsule

Placebo Comparator: Placebo
Matching placebo administered once daily in the evening
Drug: Placebos
Placebo oral capsule

Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale [ Time Frame: Day 43 ]

Secondary Outcome Measures :
  1. Clinical Global Impression Scale - Severity [ Time Frame: Day 43 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285515

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United States, California
Clinical Site
Garden Grove, California, United States, 92845
Clinical Site
Oceanside, California, United States, 92056
Clinical Site
Sherman Oaks, California, United States, 91403
United States, Florida
Clinical Site
Lauderhill, Florida, United States, 33319
Clinical Site
Miami, Florida, United States, 33122
Clinical Site
Orange City, Florida, United States, 32763
United States, Georgia
Clinical Site
Atlanta, Georgia, United States, 30331
Clinical Site
Decatur, Georgia, United States, 30030
United States, Missouri
Clinical Site
O'Fallon, Missouri, United States, 63368
United States, New York
Clinical Site
Cedarhurst, New York, United States, 11694
Clinical Site
New York, New York, United States, 10128
United States, North Carolina
Clinical Site
Charlotte, North Carolina, United States, 28211
United States, Washington
Clinical Site
Bellevue, Washington, United States, 98007
Clinical Site
Burgas, Bulgaria, 8000
Clinical Site
Kardzhali, Bulgaria, 6600
Clinical Site
Plovdiv, Bulgaria, 4004
Clinical Site
Ruse, Bulgaria, 7003
Clinical Site
Sofia, Bulgaria, 1113
Clinical Site
Sofia, Bulgaria, 1408
Clinical Site
Sofia, Bulgaria, 1431
Clinical Site
Sofia, Bulgaria, 1680
Clinical Site
Varna, Bulgaria, 9020
Clinical Site
Veliko Tarnovo, Bulgaria, 5000
Clinical Site
Vratsa, Bulgaria, 3000
Russian Federation
Clinical Site
Ekaterinburg, Russian Federation, 620030
Clinical Site
Moscow, Russian Federation, 105082
Clinical Site
Saint Petersburg, Russian Federation, 190121
Clinical Site
Saint Petersburg, Russian Federation, 192019
Clinical Site
Saint Petersburg, Russian Federation, 195160
Clinical Site
Saint Petersburg, Russian Federation, 197341
Clinical Site
Saint Petersburg, Russian Federation, 199106
Clinical Site
Tomsk, Russian Federation, 634009
Clinical Site
Belgrade, Serbia, 11000
Clinical Site
Kovin, Serbia, 26220
Clinical Site
Kragujevac, Serbia, 34000
Clinical Site
Kyiv, Ukraine, 1133
Clinical Site
Lviv, Ukraine, 79021
Clinical site
Odesa, Ukraine, 65006
Clinical Site
Odesa, Ukraine, 67513
Clinical Site
Poltava, Ukraine, 36013
Clinical Site
Smila, Ukraine, 20708
Clinical Site
Vinnytsia, Ukraine, 21005
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
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Study Director: Susan Kozauer, MD Intra-Cellular Therapies, Inc.
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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT04285515    
Other Study ID Numbers: ITI-007-403
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intra-Cellular Therapies, Inc.:
Mixed Features
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders