Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/12/2019 |
| Start Date: | November 2, 2017 |
| End Date: | June 2019 |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
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.
parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I
or Bipolar II disorder having a major depressive episode.
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
- able to provide written informed consent
Major Exclusion Criteria:
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
We found this trial at
11
sites
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