At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 381 enrolled
Drug / intervention
Lumateperone +1 moredrug
Likely dose
Lumateperone 42 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Lumateperone and Placebo for Bipolar Depression. Completed, enrolled 381 participants across 47 sites in 6 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesBulgaria, Colombia, Russia, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartNov 2017
Primary CompletionMar 2019
TodayJul 2026
First PostedAug 15, 2017
Enrollment StartNov 27, 2017
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.9 years ago
Interventions
Lumateperonedrug
Lumateperone 42 mg (ITI-007 60 mg tosylate)
Placeboother
Placebo