Actively Recruiting
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Led by Xenon Pharmaceuticals Inc. · Updated on 2026-05-05
400
Participants Needed
28
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 74 years who had their first major depressive episode before age 50
- Body Mass Index (BMI) between 18 and 40 kg/m2
- Diagnosis of bipolar I or II disorder currently in a major depressive episode confirmed by Mini International Neuropsychiatric Interview (MINI)
- Current major depressive episode lasting between 4 weeks and 12 months
You will not qualify if you...
- Diagnosis of any major depressive disorder other than bipolar depression, including psychotic, catatonia, seasonal pattern, or postpartum depression
- Any nonbipolar psychiatric diagnosis
- Substance use disorder (excluding tobacco) within 6 months before screening
- Symptomatic eating disorder within 12 months before screening
- Young Mania Rating Scale (YMRS) score greater than 12 at screening or randomization
- Hospitalization for mania within 30 days before screening
- Treatment resistance to 2 or more approved medications in the current bipolar depressive episode
- Active suicidal plan or intent within 6 months before screening or suicidal behavior within 12 months
- Self-injurious behavior without intent to die within 12 months before screening
- Use of antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within 1 week or less than 5 times the drug's half-life before randomization
- Medical conditions that interfere with study purpose or conduct
- Pregnant, breastfeeding, or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Noble Clinical Research
Tucson, Arizona, United States, 85704
Actively Recruiting
2
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Actively Recruiting
4
Clinical Innovations Inc
Bellflower, California, United States, 90706
Actively Recruiting
5
ProScience Research Group
Culver City, California, United States, 90230
Actively Recruiting
6
ATP Clinical Research
Orange, California, United States, 92866
Actively Recruiting
7
NRC Research Institute
Orange, California, United States, 92868
Actively Recruiting
8
Clinical Innovations Inc
Riverside, California, United States, 92506
Actively Recruiting
9
PharmaSouth Research, LLC
Coral Gables, Florida, United States, 33146
Actively Recruiting
10
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Actively Recruiting
11
Central Miami Medical Institute
Miami, Florida, United States, 33125
Actively Recruiting
12
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
Actively Recruiting
13
Synexus Clinical Research, Inc.
Atlanta, Georgia, United States, 30328
Actively Recruiting
14
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
15
CenExel iResearch
Decatur, Georgia, United States, 30030
Actively Recruiting
16
Denali Health Atlanta, LLC
Stone Mountain, Georgia, United States, 30083
Actively Recruiting
17
Advanced Quality Medical Research
Orland Park, Illinois, United States, 60462
Actively Recruiting
18
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
Actively Recruiting
19
Redbird Clinical Research, LLC
Las Vegas, Nevada, United States, 89119
Actively Recruiting
20
Lumina Clinical Research Center
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
21
Integrative Clinical Trials LLC
Brooklyn, New York, United States, 11229
Actively Recruiting
22
Neurobehavioral Research Inc
Cedarhurst, New York, United States, 11516
Actively Recruiting
23
DelRicht Research
Charlotte, North Carolina, United States, 28210
Actively Recruiting
24
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
25
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
Actively Recruiting
26
Elevate Synapsis, LLC
Atascocita, Texas, United States, 77346
Actively Recruiting
27
Grayline Research Center
Wichita Falls, Texas, United States, 76309
Actively Recruiting
28
Eastside Therapeutics Resources, INC dba Core Clinical Research
Everett, Washington, United States, 98201
Actively Recruiting
Research Team
X
Xenon Medical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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