Charlotte, North Carolina 28211

  • Major Depressive Disorder

Purpose:

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.


Criteria:

Major Inclusion Criteria: - Male or female subjects of any race, ages 18-75 inclusive - Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD - The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1) - Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2) - The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis - Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning - 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 - The patient has a significant risk for suicidal behavior - The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma


NCT ID:

NCT04285515


Primary Contact:

Study Director
Susan Kozauer, MD
Intra-Cellular Therapies, Inc.

ITCI Clinical Trials
Phone: 646 440 9333
Email: ITCIClinicalTrials@itci-inc.com


Backup Contact:

N/A


Location Contact:

Charlotte, North Carolina 28211
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 26, 2021

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