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Trial record 1 of 1 for:    ITI-007-402
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Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Intra-Cellular Therapies, Inc.
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc. Identifier:
First received: November 5, 2015
Last updated: August 14, 2017
Last verified: March 2017
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.

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 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

Resource links provided by NLM:

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: February 2019
Estimated Primary Completion Date: February 2019 (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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02600507

Contact: Kimberly Vanover, Ph.D.

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

Responsible Party: Intra-Cellular Therapies, Inc. Identifier: NCT02600507     History of Changes
Other Study ID Numbers: ITI-007-402
Study First Received: November 5, 2015
Last Updated: August 14, 2017

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

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on August 18, 2017