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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 : July 10, 2019
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 2, 2017
Actual Primary Completion Date : March 5, 2019
Actual Study Completion Date : March 5, 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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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. Identifier: NCT03249376     History of Changes
Other Study ID Numbers: ITI-007-404
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
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