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A study of azetukalner compared to placebo for adults with moderate-to-severe major depressive disorder

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Major Depressive Disorder, which is a mental health condition that causes persistent feelings of sadness and loss of interest in activities. The study will test a medication called azetukalner, which is also known as XPF-010. Some participants will receive azetukalner while others will receive placebo. The purpose of the study is to see if azetukalner works effectively in treating moderate-to-severe Major Depressive Disorder.

Participants will take either azetukalner capsules or placebo capsules by mouth once daily for a period of time. The dose of azetukalner that will be used is 20 milligrams per day. The study will measure changes in depression symptoms over several weeks, with particular attention to how participants feel after six weeks of treatment. The study will also look at changes in the ability to feel pleasure and overall improvement in the severity of depression symptoms.

This is a randomized, double-blind, placebo-controlled study, which means that participants will be assigned by chance to receive either the active medication or placebo, and neither the participants nor the doctors will know which treatment is being given until the study is completed. The treatment period will last up to 18 months. Participants may also continue taking their regular antidepressant medication during the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    After joining the study, you will be randomly assigned to one of two groups. One group will receive azetukalner 20 mg capsules, and the other group will receive placebo capsules that look identical but contain no active ingredient.

    You will not know which treatment you are receiving, and neither will your study doctor. This is called a double-blind design.

    You will take your assigned capsules once daily by mouth.

  2. Step 2

    Week 1 assessment

    At Week 1, you will have an assessment to measure changes in your symptoms.

    Your depression symptoms will be evaluated using a questionnaire called the HAMD-17, which is a standard tool that measures the severity of depression through 17 questions about your mood, sleep, anxiety, and other symptoms.

  3. Step 3

    Week 6 assessments

    At Week 6, you will undergo several assessments to evaluate how the treatment has affected your condition.

    Your depression symptoms will be measured again using the HAMD-17 questionnaire. The change in your score from the beginning of the study to Week 6 is the main measure of whether the treatment is working.

    You will also complete the SHAPS assessment, which measures your ability to experience pleasure from activities you normally enjoy. Changes in this score from the start of the study will be recorded.

    Your doctor will assess your overall condition using the CGI-S scale, which rates the severity of your illness. Changes in this rating from the beginning of the study will also be recorded.

  4. Step 4

    Continuation of daily treatment

    Throughout the study period, you will continue taking your assigned capsules once daily by mouth.

    The study will continue until the planned end date, which is estimated to be in July 2027.

Who can join the trial?

6 criteria

  • You must be an adult between 18 and 74 years old
  • Your first episode of major depression, which is a period of severe low mood and loss of interest in activities, must have occurred before you turned 50 years old
  • Your Body Mass Index, which is a measure of body weight in relation to height, must be 40 or less
  • You must currently meet specific medical criteria for major depressive disorder and be experiencing a major depressive episode, which will be confirmed through a structured interview
  • Your current major depressive episode must have lasted at least 6 weeks but not more than 24 months
  • Both men and women can participate in this study

Who cannot join the trial?

4 criteria

  • There are no specific exclusion criteria (reasons why you cannot join the study) listed in the available information for this clinical trial
  • However, the study doctor will review your complete medical history and current health condition to determine if you are suitable to participate
  • General safety considerations will be evaluated during the screening process (the initial check to see if you can join the study)
  • Your doctor will discuss with you any personal health factors that might affect your ability to safely participate in this research
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Investigated drugs

  • Azetukalner

    is an investigational medication being studied for the treatment of moderate-to-severe major depressive disorder. Major depressive disorder is a mental health condition that causes persistent feelings of sadness and loss of interest in daily activities. This medication is taken once daily and is being tested to see if it can help improve symptoms of depression.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against azetukalner to help researchers determine if the medication is truly effective. Some participants will receive the placebo instead of the active medication.

What is already known about the treatment

Azetukalner – Azetukalner is an investigational medication being studied in tablet form, taken by mouth once daily at a dose of 20 mg, for the treatment of moderate-to-severe major depressive disorder. This drug is currently in Phase 3 clinical trials, which means it is being tested in large groups of patients to confirm its effectiveness and monitor side effects before potential approval for general medical use. The specific way azetukalner works at the molecular level has not been publicly disclosed in available medical literature, as it is still under investigation. If approved, it would be classified as an antidepressant medication intended to help improve mood, emotional well-being, and daily functioning in people suffering from depression.

Investigated diseases

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, emptiness, and loss of interest in activities that were once enjoyable. People with this disorder experience these symptoms for at least two weeks, affecting their daily functioning and quality of life. The condition involves changes in sleep patterns, appetite, energy levels, and concentration. Individuals may also experience feelings of worthlessness or excessive guilt. The disorder can occur as a single episode or recur multiple times throughout a person's life. Without proper care, symptoms may persist for months or even years, significantly impacting personal relationships, work performance, and overall well-being.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523202-32-00Protocol codeXPF-010-D302Estimated enrolment472 patientsSponsorXenon Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).