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Clinical Trial Evaluating ITI-007 as a Monotherapy for the Treatment of Bipolar Depression

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ClinicalTrials.gov Identifier: NCT02600494
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : August 16, 2017
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: ITI-007 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
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
Actual Study Start Date : December 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

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

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
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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): NCT02600494


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

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Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc. (ITI)
More Information
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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02600494     History of Changes
Other Study ID Numbers: ITI-007-401
First Posted: November 9, 2015    Key Record Dates
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