A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
Intra-Cellular Therapies, Inc.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, 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 1 week) during which patient eligibility will be assessed. * Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg 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 visit
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to provide written informed consent before the initiation of any study specific procedures; 2. Male or female inpatient, between the ages of 18 and 75 years, inclusive; 3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT); 4. YMRS total score ≥ 20 and a scor…
Interventions
- DrugLumateperone
Lumateperone 42 mg capsules administered orally, once daily
- DrugPlacebo
Matching capsules administered orally, once daily
Locations (35)
- Clinical SiteBentonville, Arkansas
- Clinical SiteLittle Rock, Arkansas
- Clinical SiteAnaheim, California
- Clinical SiteCerritos, California
- Clinical SiteOrange, California
- Clinical SiteTorrance, California