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

• Status: Completed
• Trial end date: 2020-07-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.
• Treatments: Valproic Acid

Criteria

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