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Trial record 1 of 1 for:    ITI-007-401
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Clinical Trial Evaluating ITI-007 as a Monotherapy for the Treatment of Bipolar Depression

This study is currently recruiting participants.
Verified March 2017 by Intra-Cellular Therapies, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02600494
First Posted: November 9, 2015
Last Update Posted: August 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.
  Purpose
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 Intervention Phase
Bipolar Depression Drug: ITI-007 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

Further study details as provided by Intra-Cellular Therapies, Inc.:

Primary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

Estimated Enrollment: 550
Actual Study Start Date: December 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg ITI-007
40 mg ITI-007 administered orally as capsules once daily for 6 weeks
Drug: ITI-007
Experimental: 60 mg ITI-007
60 mg ITI-007 administered orally as capsules once daily for 6 weeks
Drug: ITI-007
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Drug: Placebo

  Eligibility

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

Major Exclusion Criteria:

  • any subject unable to provide informed consent
  • any female subject who is pregnant or breast-feeding
  • any subject judged to be medically inappropriate for study participation
  Contacts and Locations
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): NCT02600494


Contacts
Contact: Kimberly Vanover, Ph.D. itciclinicaltrials@intracellulartherapies.com

  Show 45 Study Locations
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc. (ITI)
  More Information

Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02600494     History of Changes
Other Study ID Numbers: ITI-007-401
First Submitted: November 5, 2015
First Posted: November 9, 2015
Last Update Posted: August 16, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders