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Azetukalner versus placebo for depressive episodes in bipolar I or II

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)

Phase 3 Interventional Xenon Pharmaceuticals Inc. · NCT07172516

This study will test whether azetukalner helps adults with bipolar I or II who are currently in a depressive episode feel better than a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorXenon Pharmaceuticals Inc. Industry-sponsored
Locations28 sites (Tucson, Arizona and 27 other locations)
Trial IDNCT07172516 on ClinicalTrials.gov

What this trial studies

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing azetukalner to placebo in adults with bipolar I or II disorder who are currently experiencing a major depressive episode. Participants are randomized to receive azetukalner or matched placebo and are monitored for improvement in depressive symptoms and for safety outcomes. Eligible adults are 18–74 years old with a current depressive episode lasting 4 weeks to 12 months and first MDE before age 50, and key exclusions include nonbipolar psychiatric disorders and recent substance use disorder. The trial is being conducted at several US clinical research sites with standardized diagnostic interviews to confirm bipolar depression.

Who should consider this trial

Good fit: Adults aged 18–74 with DSM-5-TR bipolar I or II disorder in a current major depressive episode of 4 weeks to 12 months' duration, first MDE before age 50, and BMI between 18 and 40 kg/m2 are the intended participants.

Not a fit: People with a primary major depressive disorder diagnosis, nonbipolar psychiatric diagnoses, recent substance use disorder, symptomatic eating disorder, or who fall outside the age/BMI limits are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, azetukalner could provide a new medication option to reduce depressive symptoms in adults with bipolar I or II disorder.

How similar studies have performed: Earlier-phase studies supported moving azetukalner into Phase 3, but large-scale proof of clinical benefit in bipolar depression has not yet been established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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 Mania Rating Scale (YMRS) score \>12 points at screening visit or randomization.
* Participant has been hospitalized for mania within the 30 days prior to screening visit.
* Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).
* Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.
* Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
* Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
* Participants with medical conditions that may interfere with the purpose or conduct of the study.
* Participant is pregnant, breastfeeding, or planning to become pregnant.

Where this trial is running

Tucson, Arizona and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar DisorderBipolar DepressionBipolar I DisorderBipolar II DisorderBipolarXEN1101Azetukalner
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.