CompletedPhase 3

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

United States554 participantsStarted 2015-12-15

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Timeframe: 6 weeks

Trial details

NCT IDNCT02600494

SponsorIntra-Cellular Therapies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-28

Results submitted2025-03-04

View on ClinicalTrials.gov More Bipolar Depression trials