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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.
 
ClinicalTrials.gov Identifier: NCT03249376
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE August 11, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE November 2, 2017
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Day 43 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • Clinical Global Impression Scale, Bipolar version (CGI-BP) [ Time Frame: Day 43 ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: Day 43 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Depression
Intervention  ICMJE
  • Drug: Lumateperone
    Lumateperone (ITI-007 60 mg)
    Other Name: ITI-007
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Lumateperone
    Lumateperone (ITI-007 60 mg) administered once daily every evening for 6 weeks
    Intervention: Drug: Lumateperone
  • Placebo Comparator: Placebo
    Placebo administered once daily every evening for 6 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
381
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2017)
250
Actual Study Completion Date  ICMJE April 9, 2019
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Colombia,   Russian Federation,   Serbia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249376
Other Study ID Numbers  ICMJE ITI-007-404
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Intra-Cellular Therapies, Inc.
Study Sponsor  ICMJE Intra-Cellular Therapies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Susan Kozauer, MD Intra-Cellular Therapies, Inc.
PRS Account Intra-Cellular Therapies, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP