Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

May 10, 2022 updated by: Intra-Cellular Therapies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • Clinical Site
      • Kardzhali, Bulgaria
        • Clinical Site
      • Lovech, Bulgaria
        • Clinical Site
      • Plovdiv, Bulgaria
        • Clinical Site
      • Ruse, Bulgaria
        • Clinical Site
      • Sofia, Bulgaria
        • Clinical Site
      • Targovishte, Bulgaria
        • Clinical Site
      • Tsarev Brod, Bulgaria
        • Clinical Site
      • Varna, Bulgaria
        • Clinical Site
      • Veliko Tarnovo, Bulgaria
        • Clinical Site
  • Colombia
      • Barranquilla, Colombia
        • Clinical Site
      • Bello, Colombia
        • Clinical Site
      • Pereira, Colombia
        • Clinical Site
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Clinical Site
      • Moscow, Russian Federation
        • Clinical Site
      • Nizhny Novgorod, Russian Federation
        • Clinical Site
      • Omsk, Russian Federation
        • Clinical Site
      • Saint Petersburg, Russian Federation
        • Clinical Site
      • Samara, Russian Federation
        • Clinical Site
      • Saratov, Russian Federation
        • Clinical Site
      • Tomsk, Russian Federation
        • Clinical Site
  • Serbia
      • Belgrade, Serbia
        • Clinical Site
      • Kragujevac, Serbia
        • Clinical Site
      • Novi Sad, Serbia
        • Clinical Site
  • Ukraine
      • Ivano-Frankivs'k, Ukraine
        • Clinical Site
      • Kharkiv, Ukraine
        • Clinical Site
      • Kherson, Ukraine
        • Clinical Site
      • Lviv, Ukraine
        • Clinical Site
      • Odesa, Ukraine
        • Clinical Site
      • Poltava, Ukraine
        • Clinical Site
      • Smila, Ukraine
        • Clinical Site
      • Uzhgorod, Ukraine
        • Clinical Site
      • Vinnytsia, Ukraine
        • Clinical Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Clinical Site
    • California
      • Sherman Oaks, California, United States, 91403
        • Clinical Site
    • Florida
      • Miami, Florida, United States, 33133
        • Clinical Site
      • Orange City, Florida, United States, 32763
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Clinical Site
      • Decatur, Georgia, United States, 30030
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Clinical Site
      • Joliet, Illinois, United States, 60435
        • Clinical Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Clinical Site
    • New York
      • Buffalo, New York, United States, 14215
        • Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Clinical Site
    • Texas
      • The Woodlands, Texas, United States, 77381
        • Clinical Site
    • Washington
      • Bothell, Washington, United States, 98011
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumateperone
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks
Drug: Lumateperone
Lumateperone 42 mg (ITI-007 60 mg tosylate)
Other Names:
  • ITI-007
Placebo Comparator: Placebo
Placebo administered once daily every evening for 6 weeks
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline to Day 43
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Baseline to Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
Time Frame: Baseline to Day 43
The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
Baseline to Day 43
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
Time Frame: Baseline to Day 43
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.
Baseline to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Susan Kozauer, MD, Intra-Cellular Therapies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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