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Azetukalner for Bipolar Depression Study

This study is looking at a medication called azetukalner to see if it can help adults with bipolar I or II disorder who are currently experiencing a depressive episode (bipolar depression). You would take azetukalner or a placebo (an inactive pill) once a day with food for 6 weeks. Researchers will measure changes in your depression symptoms using a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS) to see how well the treatment works. We are looking for 400 participants between 18 and 74 years old who were diagnosed with their first major depressive episode before age 50. The current recruitment status is unclear.

Study design
This is a Phase 3, randomized, double-blind, placebo-controlled study involving about 400 participants. This means participants will be randomly assigned to receive either azetukalner or a placebo, and neither you nor your doctor will know which you are receiving.
What's involved
You would take azetukalner or a placebo orally once a day with food (preferably with your evening meal) for 6 weeks. Your depression symptoms will be measured at the beginning of the study and again at Week 6.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured at Week 6, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07172516

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Recruiting
PHASE3Ages 18–74InterventionalTreatment
Xenon Pharmaceuticals Inc.
~400 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:AzetukalnerPlacebo

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
Measured over Baseline to Week 6

Conditions

Bipolar Disorder
Bipolar Depression
Bipolar I Disorder
Bipolar II Disorder

Explore related trials

Bipolar I disorderBipolar II Disorder

Where it's being run

28 sites across 15 states
California5
Florida4
Georgia4
Arkansas2
New York2
Texas2
Arizona1
Illinois1

Who to contact

Xenon Medical Affairs
[email protected]
1-604-484-3300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.Baseline to Week 6