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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
529

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intra-Cellular Therapies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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