Identification Module
The Identification Module contains basic identifying information about the clinical trial, including the NCT ID, brief title, official title, acronym, organization study ID information, and organization details. This module provides essential identifiers for the trial.
Identification Module path is as follows:
Study -> Protocol Section -> Identification Module
Identification Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02600494
Brief Title:
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension 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 (Bipolar Depression)
Study:
NCT02600494
Protocol Section:
NCT02600494