At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 554 enrolled
Drug / intervention
ITI-007 (Lumateperone) +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.
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)
In Brief
A Phase 3 clinical trial evaluating ITI-007 (Lumateperone) and Placebo for Bipolar Depression. Completed, enrolled 554 participants across 55 sites.
Detailed Summary
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionJan 2019
Study CompletionJul 2019
TodayJul 2026
First PostedNov 9, 2015
Enrollment StartDec 15, 2015
Primary CompletionJan 28, 2019
Study CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.6 years ago
Interventions
ITI-007 (Lumateperone)drug
Placebodrug