A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
Intra-Cellular Therapies, Inc.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Description
The study will be conducted in 3 phases: * Screening Period (up to 2 weeks) during which patient eligibility will be assessed * Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone or placebo in 1:1 ratio. * Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately one week after the last dose of study drug.
Eligibility
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to provide consent as follows: * The Legally Authorized Representative (LAR) must provide written, informed consent. * The patient must provide written assent; 2. Male or female patients 10 to 17 years of age, inclusive; 3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 4. Subje…
Interventions
- DrugLumateperone
Lumateperone administered orally, once daily.
- DrugPlacebo
Matching placebo administered orally, once daily.
Locations (59)
- Clinical SiteDothan, Alabama
- Clinical SiteLittle Rock, Arkansas
- Clinical SiteAnaheim, California
- Clinical SiteRedlands, California
- Clinical SiteSacramento, California
- Clinical SiteSan Diego, California