A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
NCT ID: NCT07076407
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-07-08
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Azetukalner
Azetukalner 20 mg
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
Placebo
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Interventions
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Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
74 Years
ALL
No
Sponsors
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Xenon Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Harmonex Neuroscience Research
Dothan, Alabama, United States
University of Alabama at Birmingham, Huntsville Regional Medical Campus
Huntsville, Alabama, United States
Pillar Clinical Research
Bentonville, Arkansas, United States
SanRo Clinical Research Group
Bryant, Arkansas, United States
Clinical Innovations Inc
Bellflower, California, United States
Center for Neurohealth
La Jolla, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Neuroscience Research
Sherman Oaks, California, United States
Pacific Clinical Research Management Group
Upland, California, United States
Institute of Living
Hartford, Connecticut, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Equipath Health and Research Tampa Bay, Llc
Riverview, Florida, United States
Delricht Research
Atlanta, Georgia, United States
Advanced Quality Medical Research
Orland Park, Illinois, United States
Pharmasite Research Inc.
Baltimore, Maryland, United States
Adams Clinical Boston
Boston, Massachusetts, United States
Activmed Practices & Research, Llc - Methuen
Methuen, Massachusetts, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Fieve Clinical Research, Inc.
New York, New York, United States
Magnolia Clinical Research, Llc
Cary, North Carolina, United States
Insight Clinical Trials
Independence, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Austin Clinical Trial Partners
Austin, Texas, United States
Boeson Research
Provo, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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XPF-010-D302
Identifier Type: -
Identifier Source: org_study_id
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