Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 134 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02600494
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 554 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 : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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



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


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.


Layout table for eligibility information
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

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


  Show 45 Study Locations
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
Layout table for investigator information
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc. (ITI)

Layout table for additonal information
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: December 20, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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