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Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

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: NCT02600494
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE November 5, 2015
First Posted Date  ICMJE November 9, 2015
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date January 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Official Title  ICMJE Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
Brief Summary The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
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: ITI-007 (Lumateperone)
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 40 mg ITI-007 (Lumateperone)
    40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
    Intervention: Drug: ITI-007 (Lumateperone)
  • Experimental: 60 mg ITI-007 (Lumateperone)
    60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
    Intervention: Drug: ITI-007 (Lumateperone)
  • Placebo Comparator: Placebo
    Placebo administered orally as visually-matched capsules once daily for 6 weeks
    Intervention: Drug: 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: December 18, 2018)
554
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2015)
550
Actual Study Completion Date  ICMJE July 24, 2019
Actual Primary Completion Date January 28, 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

Major Exclusion Criteria:

  • any subject unable to provide informed consent
  • 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02600494
Other Study ID Numbers  ICMJE ITI-007-401
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 Not Provided
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. (ITI)
PRS Account Intra-Cellular Therapies, Inc.
Verification Date January 2020

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