NCT07172516 · Xenon Pharmaceuticals Inc.
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
(X-CEED)
What this study is about
X-CEED is a Phase 3, conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study to evaluate the effectiveness and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
View original scientific description
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).
Interventions
DRUG
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
DRUG
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Primary outcome measures
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
Time frame: Baseline to Week 6
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Key
Exclusion criteria
- Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- Participant has any nonbipolar psychiatric diagnosis.
- Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
- Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
- Participant has a Young Ma
Where
- Tucson, Arizona
- Little Rock, Arkansas
- Rogers, Arkansas
- Bellflower, California
- Culver City, California
- Orange, California
- Riverside, California
- Coral Gables, Florida
- Jacksonville, Florida
- Miami, Florida
- Orlando, Florida
- Atlanta, Georgia
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations