At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 529 enrolled
Drug / intervention
Lumateperone (ITI-007) +1 moredrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 3 clinical trial evaluating Lumateperone (ITI-007) and Placebo for Bipolar Depression. Completed, enrolled 529 participants across 71 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesBulgaria, Russia, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartMar 2016
Primary CompletionJul 2020
TodayJul 2026
First PostedNov 9, 2015
Enrollment StartMar 7, 2016
Primary CompletionJul 2, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.6 years ago
Interventions
Lumateperone (ITI-007)drug
Placebodrug