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

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ClinicalTrials.gov Identifier: NCT02600494
Recruitment Status : Completed
First Posted : November 9, 2015
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 (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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: ITI-007 (Lumateperone) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : July 24, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 40 mg ITI-007 (Lumateperone)
40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Drug: ITI-007 (Lumateperone)
Experimental: 60 mg ITI-007 (Lumateperone)
60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
Drug: ITI-007 (Lumateperone)
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Drug: Placebo

Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

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, 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

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): NCT02600494

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Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
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Study Director: Susan Kozauer, MD Intra-Cellular Therapies, Inc. (ITI)
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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02600494    
Other Study ID Numbers: ITI-007-401
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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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