Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | December 2017 |
| Contact: | Kimberly Vanover, Ph.D. |
| Email: | kvanover@intracellulartherapies.com |
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
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.
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.
Inclusion Criteria:
- male or female subjects of any race, ages 18-65 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
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