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 (27) 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
Arizona
Noble Clinical Research
RECRUITING
Tucson
California
Clinical Innovations Inc
RECRUITING
Bellflower
ProScience Research Group
RECRUITING
Culver City
ATP Clinical Research
RECRUITING
Orange
NRC Research Institute
RECRUITING
Orange
Clinical Innovations Inc
RECRUITING
Riverside
Florida
PharmaSouth Research, LLC
RECRUITING
Coral Gables
Clinical Neuroscience Solutions, Inc.
RECRUITING
Jacksonville
Central Miami Medical Institute
RECRUITING
Miami
Clinical Neuroscience Solutions, Inc
RECRUITING
Orlando
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
Synexus Clinical Research, Inc.
RECRUITING
Atlanta
CenExel iResearch
RECRUITING
Decatur
Denali Health Atlanta, LLC
RECRUITING
Stone Mountain
Missouri
Psychiatric Care and Research Center
RECRUITING
O'fallon
North Carolina
DelRicht Research
RECRUITING
Charlotte
New Jersey
Lumina Clinical Research Center
RECRUITING
Cherry Hill
Nevada
Redbird Clinical Research, LLC
RECRUITING
Las Vegas
New York
Integrative Clinical Trials LLC
RECRUITING
Brooklyn
Neurobehavioral Research Inc
RECRUITING
Cedarhurst
Pennsylvania
Lehigh Center for Clinical Research
RECRUITING
Allentown
Tennessee
Clinical Neuroscience Solutions, Inc
RECRUITING
Memphis
Texas
Elevate Synapsis, LLC
RECRUITING
Atascocita
Grayline Research Center
RECRUITING
Wichita Falls
Washington
Eastside Therapeutics Resources, INC dba Core Clinical Research
RECRUITING
Everett
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.