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Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

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ClinicalTrials.gov Identifier: NCT03249376
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Study Description
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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

Study Design
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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

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Arms and Interventions
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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
Placebo


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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): NCT03249376


  Show 47 Study Locations
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
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Study Director: Susan Kozauer, MD Intra-Cellular Therapies, Inc.
More Information
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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov 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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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Bipolar and Related Disorders