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New depression pill could lift the fog without lifelong dependence

NCT ID NCT06775379

Symptom relief Sponsor: Xenon Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether a new medication called azetukalner can reduce depression symptoms in adults with moderate-to-severe major depressive disorder. About 450 participants will receive either the drug or a placebo for 6 weeks. The main goal is to see if the drug improves mood and pleasure, as measured by standard depression scales.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accel Research Sites - St. Petersburg-Largo

    RECRUITING

    Largo, Florida, 33777, United States

  • Accel Research Sites Lakeland

    RECRUITING

    Lakeland, Florida, 33803, United States

  • Adams Clinical - Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Advanced Discovery Research

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Aim Trials, Llc

    RECRUITING

    Plano, Texas, 75093, United States

  • Atp Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Behavioral Research Specialists, Llc

    RECRUITING

    Glendale, California, 91206, United States

  • Boston Clinical Trials Llc

    RECRUITING

    Boston, Massachusetts, 02131, United States

  • CNS Clinical Research Group

    RECRUITING

    Coral Springs, Florida, 33067, United States

  • CalNeuro Research Group, Inc.

    RECRUITING

    Los Angeles, California, 90025, United States

  • CenExel CNS-TO (Collaborative Neuroscience Research)

    RECRUITING

    Torrance, California, 90504, United States

  • CenExel iResearch

    ACTIVE_NOT_RECRUITING

    Decatur, Georgia, 30030, United States

  • Cenexel Iresearch - Savannah

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Combined Research Orlando Phase I-Iv

    ACTIVE_NOT_RECRUITING

    Orlando, Florida, 32807, United States

  • Core Clinical Research

    RECRUITING

    Everett, Washington, 98201, United States

  • Ct Clinical Research Associates

    RECRUITING

    Cromwell, Connecticut, 06416, United States

  • Delricht Research - Plano

    RECRUITING

    Plano, Texas, 75024, United States

  • ELIXIA

    RECRUITING

    Springfield, Massachusetts, 01103, United States

  • Excell Research Inc.

    RECRUITING

    Oceanside, California, 92056, United States

  • Grayline Research Center

    RECRUITING

    Wichita Falls, Texas, 76309, United States

  • Harmony Clinical Research Inc

    ACTIVE_NOT_RECRUITING

    North Miami Beach, Florida, 33162, United States

  • IMA Clinical Research

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60634, United States

  • IMA Clinical Research

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • IMA Clinical Research Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • IMA Clinical Research Phoenix

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Integrative Clinical Trials

    RECRUITING

    Brooklyn, New York, 11229, United States

  • Irvine Clinical Research

    RECRUITING

    Irvine, California, 92614, United States

  • Kinetic Clinical Research, LLC

    RECRUITING

    West Covina, California, 91790, United States

  • Lehigh Center For Clinical Research

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Marvel Clinical Research

    WITHDRAWN

    Huntington Beach, California, 92647, United States

  • Mountain View Clinical Research

    RECRUITING

    Denver, Colorado, 80209, United States

  • NeoClinical Research

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33016, United States

  • Neuro-Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • New Hope Clinical Research

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Northwest Clinical Trials Inc

    RECRUITING

    Boise, Idaho, 83704, United States

  • Nrc Research Institute

    RECRUITING

    Orange, California, 92868, United States

  • Pahl Pharmaceutical Professionals Llc

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Panhandle Research and Medical Clinic

    RECRUITING

    Pensacola, Florida, 32503, United States

  • PharmaSouth Research

    RECRUITING

    Miami, Florida, 33165, United States

  • Psych Atlanta, Pc

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Quantum Clinical Trials

    TERMINATED

    Miami Beach, Florida, 33140, United States

  • Redbird Research

    ACTIVE_NOT_RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10314, United States

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Synexus - Atlanta

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Tekton Research

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest

    RECRUITING

    Rogers, Arkansas, 72758, United States

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