Back to search results

X-NOVA3: Azetukalner for Major Depressive Disorder

This study, called X-NOVA3, is testing a new medication called Azetukalner for adults with Major Depressive Disorder (MDD). Researchers want to see if Azetukalner, taken once a day for 6 weeks, can help reduce symptoms of depression compared to a placebo (an inactive pill). You might be able to join if you are between 18 and 74 years old, have a diagnosis of MDD, and experienced your first depressive episode before age 50. The main way success will be measured is by looking at changes in your depression symptoms using a standard rating scale after 6 weeks. The current recruitment status for this study is unclear.

Study design
This is a Phase 3 study involving about 450 participants. It is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either Azetukalner or a placebo, and neither you nor your doctors will know which you are receiving.
What's involved
You would take Azetukalner or a placebo orally once a day with food for 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 6.

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

NCT07076407

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

Recruiting
PHASE3Ages 18–74InterventionalTreatment
Xenon Pharmaceuticals Inc.
~450 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:AzetukalnerPlacebo

At a glance

Recruiting sites
46 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
Measured over Baseline to Week 6

Conditions

Major Depressive Disorder

Explore related trials

Unipolar Depression

Where it's being run

48 sites across 24 states
California5
Massachusetts4
Poland4
Florida3
New Jersey3
New York3
Alabama2
Arkansas2

Who to contact

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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age
Body Mass Index (BMI) ≤40 kg/m2
Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)
Participant's current MDE has a duration of ≥6 weeks and ≤24 months.

Exclusion

Participant has a primary diagnosis of a mood disorder other than MDD.
Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.
Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.
Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.
Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or \>1 suicide attempt \> 24 years of age.
Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.
Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.
Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).
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 Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6Baseline to Week 6

    The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.