CompletedPhase 3

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

United States381 participantsStarted 2017-11-27

Plain-language 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.

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 * able to provide written informed consent Major Exclusion Criteria: * 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 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Timeframe: Baseline to Day 43

Trial details

NCT IDNCT03249376

SponsorIntra-Cellular Therapies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-01

Results submitted2022-04-20

View on ClinicalTrials.gov More Bipolar Depression trials