A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
NCT ID: NCT06775379
Last Updated: 2025-10-22
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
2024-12-20
2026-10-31
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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IMA Clinical Research Phoenix
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Behavioral Research Specialists, Llc
Glendale, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Irvine Clinical Research
Irvine, California, United States
CalNeuro Research Group, Inc.
Los Angeles, California, United States
Excell Research Inc.
Oceanside, California, United States
Atp Clinical Research
Orange, California, United States
Nrc Research Institute
Orange, California, United States
CenExel CNS-TO (Collaborative Neuroscience Research)
Torrance, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Ct Clinical Research Associates
Cromwell, Connecticut, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
NeoClinical Research
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Accel Research Sites Lakeland
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg-Largo
Largo, Florida, United States
PharmaSouth Research
Miami, Florida, United States
Quantum Clinical Trials
Miami Beach, Florida, United States
Harmony Clinical Research Inc
North Miami Beach, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Combined Research Orlando Phase I-Iv
Orlando, Florida, United States
Panhandle Research and Medical Clinic
Pensacola, Florida, United States
Advanced Discovery Research
Atlanta, Georgia, United States
Synexus - Atlanta
Atlanta, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
Psych Atlanta, Pc
Marietta, Georgia, United States
Cenexel Iresearch - Savannah
Savannah, Georgia, United States
Northwest Clinical Trials Inc
Boise, Idaho, United States
Chicago Research Center Inc.
Chicago, Illinois, United States
Boston Clinical Trials Llc
Boston, Massachusetts, United States
ELIXIA
Springfield, Massachusetts, United States
IMA Clinical Research Las Vegas
Las Vegas, Nevada, United States
Redbird Research
Las Vegas, Nevada, United States
IMA Clinical Research
Albuquerque, New Mexico, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Pahl Pharmaceutical Professionals Llc
Oklahoma City, Oklahoma, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Delricht Research - Plano
Plano, Texas, United States
Aim Trials, Llc
Plano, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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XPF-010-D301
Identifier Type: -
Identifier Source: org_study_id
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