Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

April 24, 2023 updated by: Intra-Cellular Therapies, Inc.

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate 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)

529

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
      • Pleven, Bulgaria
        • Clinical Site
      • Plovdiv, Bulgaria
        • Clinical Site
      • Ruse, Bulgaria
        • Clinical Site
      • Sofia, Bulgaria
        • Clinical Site
      • Varna, Bulgaria
        • Clinical Site
      • Veliko Tarnovo, Bulgaria
        • Clinical Site
      • Vratsa, Bulgaria
        • Clinical Site
  • Russian Federation
      • 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
      • Kovin, Serbia
        • Clinical Site
      • Novi Sad, Serbia
        • Clinical Site
      • Sumadija, Serbia
        • Clinical Site
  • Ukraine
      • Ivano-Frankivs'k, Ukraine
        • Clinical Site
      • Kharkiv, Ukraine
        • Clinical Site
      • Kropyvnytskyi, Ukraine
        • Clinical Site
      • Odesa, Ukraine
        • Clinical Site
      • Poltava, Ukraine
        • Clinical Site
      • Smila, Ukraine
        • Clinical Site
      • Vasylkiv, Ukraine
        • Clinical Site
      • Vinnytsia, Ukraine
        • Clinical Site
  • United States
    • Arkansas
      • Rogers, Arkansas, United States
        • Clinical Site
    • California
      • Cerritos, California, United States
        • Clinical Site
      • Costa Mesa, California, United States
        • Clinical Site
      • Culver City, California, United States
        • Clinical Site
      • Garden Grove, California, United States
        • Clinical Site
      • Glendale, California, United States
        • Clinical Site
      • Lemon Grove, California, United States
        • Clinical Site
      • Oceanside, California, United States
        • Clinical Site
      • Pico Rivera, California, United States
        • Clinical Site
      • Riverside, California, United States
        • Clinical Site
      • San Diego, California, United States
        • Clinical Site
      • Santa Rosa, California, United States
        • Clinical Site
      • Sherman Oaks, California, United States
        • Clinical Site
      • Temecula, California, United States
        • Clinical Site
    • Florida
      • Jacksonville, Florida, United States
        • Clinical Site
      • Lauderhill, Florida, United States
        • Clinical Site
      • Miami, Florida, United States
        • Clinical Site
      • Orange City, Florida, United States
        • Clinical Site
      • Orlando, Florida, United States
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States
        • Clinical Site
      • Savannah, Georgia, United States
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States
        • Clinical Site
    • Louisiana
      • Lake Charles, Louisiana, United States
        • Clinical Site
    • Maryland
      • Baltimore, Maryland, United States
        • Clinical Site
    • Missouri
      • O'Fallon, Missouri, United States
        • Clinical Site
      • Saint Louis, Missouri, United States
        • Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Clinical Site
    • New Jersey
      • Berlin, New Jersey, United States
        • Clinical Site
      • Cherry Hill, New Jersey, United States
        • Clinical Site
      • Toms River, New Jersey, United States
        • Clinical Site
    • New York
      • Cedarhurst, New York, United States
        • Clinical Site
      • New York, New York, United States
        • Clinical Site
      • Rochester, New York, United States
        • Clinical Site
      • Staten Island, New York, United States
        • Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Clinical Site
      • Dayton, Ohio, United States
        • Clinical Site
      • Garfield Heights, Ohio, United States
        • Clinical Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Clinical Site
      • Philadelphia, Pennsylvania, United States
        • Clinical Site
    • Texas
      • The Woodlands, Texas, United States
        • Clinical Site
    • Washington
      • Everett, Washington, United States
        • 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

Description

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
  • treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms

Exclusion Criteria:

  • any subject unable to provide informed consent
  • any female subject who is pregnant or breastfeeding
  • 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
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Drug: Placebo
Experimental: Lumateperone 28 mg (ITI-007 40 mg tosylate)
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Drug: Lumateperone (ITI-007)
Experimental: Lumateperone 42 mg (ITI-007 60 mg tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Drug: Lumateperone (ITI-007)

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-Severity (CGI-BP-S) Depression Score
Time Frame: Baseline to Day 43
The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill).
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.

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)

March 7, 2016

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-402

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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