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Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

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. Identifier: NCT03249376
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : April 14, 2021
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Lumateperone Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 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) Conducted Globally
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lumateperone
Lumateperone (ITI-007 60 mg) administered once daily every evening for 6 weeks
Drug: Lumateperone
Lumateperone (ITI-007 60 mg)
Other Name: ITI-007

Placebo Comparator: Placebo
Placebo administered once daily every evening for 6 weeks
Other: Placebo

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

Secondary Outcome Measures :
  1. Clinical Global Impression Scale, Bipolar version (CGI-BP) [ Time Frame: Day 43 ]
  2. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Day 43 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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, with a clinical diagnosis of Bipolar I or Bipolar II disorder
  • experiencing a current major depressive episode
  • 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

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 identifier (NCT number): NCT03249376

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United States, Alabama
Clinical Site
Birmingham, Alabama, United States, 35294
United States, California
Clinical Site
Sherman Oaks, California, United States, 91403
United States, Florida
Clinical Site
Miami, Florida, United States, 33133
Clinical Site
Orange City, Florida, United States, 32763
United States, Georgia
Clinical Site
Atlanta, Georgia, United States, 30322
Clinical Site
Decatur, Georgia, United States, 30030
United States, Illinois
Clinical Site
Chicago, Illinois, United States, 60612
Clinical Site
Joliet, Illinois, United States, 60435
United States, Louisiana
Clinical Site
Shreveport, Louisiana, United States, 71101
United States, Missouri
Clinical Site
Saint Louis, Missouri, United States, 63128
United States, New York
Clinical Site
Buffalo, New York, United States, 14215
United States, North Carolina
Clinical Site
Charlotte, North Carolina, United States, 28211
United States, Texas
Clinical Site
The Woodlands, Texas, United States, 77381
United States, Washington
Clinical Site
Bothell, Washington, United States, 98011
Clinical Site
Burgas, Bulgaria
Clinical Site
Kardzhali, Bulgaria
Clinical Site
Lovech, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Ruse, Bulgaria
Clinical Site
Sofia, Bulgaria
Clinical Site
Targovishte, Bulgaria
Clinical Site
Tzarev Brod, Bulgaria
Clinical Site
Varna, Bulgaria
Clinical Site
Veliko Tarnovo, Bulgaria
Clinical Site
Barranquilla, Colombia
Clinical Site
Bello, Colombia
Clinical Site
Pereira, Colombia
Russian Federation
Clinical Site
Ekaterinburg, Russian Federation
Clinical Site
Moscow, Russian Federation
Clinical Site
Nizhny Novgorod, Russian Federation
Clinical Site
Omsk, Russian Federation
Clinical Site
Saint Petersburg, Russian Federation
Clinical Site
Samara, Russian Federation
Clinical Site
Saratov, Russian Federation
Clinical Site
Tomsk, Russian Federation
Clinical Site
Belgrade, Serbia
Clinical Site
Kragujevac, Serbia
Clinical Site
Novi Sad, Serbia
Clinical Site
Ivano-Frankivs'k, 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
Uzhgorod, Ukraine
Clinical Site
Vinnytsia, Ukraine
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
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Study Director: Susan Kozauer, MD Intra-Cellular Therapies, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Intra-Cellular Therapies, Inc. Identifier: NCT03249376    
Other Study ID Numbers: ITI-007-404
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders