Phase 3 N=554 Randomized Quadruple-blind Treatment

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT02600494 ↗

Enrolled (actual)

554

Serious AEs

1.5%

Results posted

Nov 2025

Primary outcome: Primary: Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -18.9; -20.7; -19.7 score on a scale — p=0.514

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ITI-007 (Lumateperone) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Intra-Cellular Therapies, Inc.
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	-18.9; -20.7; -19.7	0.514
SECONDARY Time to First Sustained Response in Reduction of MADRS Total Score	43; 38; 37	0.993

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.

Eligibility Criteria

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

Major Exclusion Criteria:

any subject unable to provide informed consent
any female subject who is pregnant or breast-feeding
any subject judged to be medically inappropriate for study participation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02600494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.