A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Intra-Cellular Therapies, Inc.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Description
The study will be conducted in three periods: * Screening Period (up to 2 weeks) during which patient eligibility will be assessed. * Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio. * Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients between the ages of 18 and 65 years, inclusive; 2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria: 1. The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening; 2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥…
Interventions
- DrugLumateperone
Lumateperone 42 mg capsules administered orally, once daily
- DrugPlacebo
Matching capsules administered orally, once daily
Locations (60)
- Clinical SiteHuntsville, Alabama
- Clinical SitePico Rivera, California
- Clinical SiteFarmington, Connecticut
- Clinical SiteClermont, Florida
- Clinical SiteHialeah, Florida
- Clinical SiteMiami, Florida