A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
• Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
• Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
• Current MDE must has a duration of ≥4 weeks and ≤12 months.
Locations
United States
Arkansas
Woodland International Research Group
RECRUITING
Little Rock
Woodland Research Northwest
RECRUITING
Rogers
California
ATP Clinical Research
RECRUITING
Orange
Florida
PharmaSouth Research, LLC
RECRUITING
Coral Gables
Clinical Neuroscience Solutions, Inc.
RECRUITING
Jacksonville
Clinical Neuroscience Solutions, Inc
RECRUITING
Orlando
New Jersey
Center For Emotional Fitness
RECRUITING
Cherry Hill
Tennessee
Clinical Neuroscience Solutions, Inc
RECRUITING
Memphis
Texas
Grayline Research Center
RECRUITING
Wichita Falls
Contact Information
Primary
Xenon Medical Affairs
XenonCares@xenon-pharma.com
1-604-484-3300
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2028-08
Participants
Target number of participants: 400
Treatments
Experimental: Azetukalner
Azetukalner 20 mg
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: Xenon Pharmaceuticals Inc.