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A study to evaluate the effectiveness and safety of azetukalner in patients experiencing depressive episodes associated with bipolar disorder.

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What is this trial about?

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

This study focuses on individuals experiencing Bipolar Depression, which refers to periods of intense sadness or low mood that occur in people diagnosed with Bipolar I Disorder or Bipolar II Disorder. These conditions involve significant shifts in mood, energy, and activity levels. The purpose of the study is to evaluate the effectiveness and safety of a medication called azetukalner, also known by its code name XPF-010, in treating these depressive periods.

Participants in the study will be assigned to receive either a 20 mg oral capsule of azetukalner or a placebo. The study uses a double-blind method, meaning neither the participants nor the researchers know which treatment is being administered at any given time. This approach helps ensure that the results are not influenced by expectations. During the course of the study, participants will take the assigned capsule once daily.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment phase

    You will receive either azetukalner (20 mg) or a placebo (an inactive substance with no medicinal effect).

    The medication is taken in the form of a capsule.

    The dose is administered orally (by mouth) once every day.

    This treatment stage lasts for 6 weeks.

  2. Step 2

    Assessment of results

    The effectiveness and safety of the treatment are evaluated through specific scales.

    At week 1, a change in the madrs total score (a scale used to measure the severity of depression) is measured.

    At week 6, the madrs total score, the cgi-s score (a scale used to measure clinical improvement), and the shaps total score (a scale used to measure the ability to feel pleasure) are measured.

Who can join the trial?

5 criteria

  • You must be an adult between the ages of 18 and 74.
  • You must have experienced your first major depressive episode (a period of intense sadness and loss of interest) before the age of 50.
  • Your Body Mass Index (BMI), which is a measure of your weight relative to your height, must be between 18 and 40.
  • You must meet the specific medical guidelines for Bipolar I or II disorder, which are conditions involving significant shifts in mood, as confirmed by a standardized clinical interview.
  • You must currently be experiencing a major depressive episode that has lasted for at least 4 weeks but no longer than 12 months.

Who cannot join the trial?

10 criteria

  • You have Major Depressive Disorder (MDD), which is a severe form of depression that may include psychotic features (losing touch with reality), catatonia (a state where a person cannot move or speak normally), seasonal patterns (depression that changes with the seasons), or postpartum depression (depression occurring after childbirth).
  • You are pregnant, breastfeeding, or are planning to become pregnant.
  • You have any other psychiatric diagnosis, which means any other diagnosed mental health condition that is not related to bipolar disorder.
  • You have had a substance use disorder, which is a problem with using drugs or alcohol, within the 6 months before the study, though using tobacco is allowed.
  • Your YMRS score is higher than 12 points, which is a scale used by doctors to measure the severity of mania (a state of abnormally high energy or mood).
  • You have been in the hospital for mania within the 30 days before the study starts.
  • You are considered treatment-resistant for your current depressive episode, meaning you have not seen improvement after taking at least two different approved medications at the correct dose for at least 6 weeks.
  • You have had an active plan or intent to commit suicide, or have shown suicidal behavior, before the study begins.
  • You have used antidepressants, mood stabilizers (medicine to balance moods), anticonvulsants (medicine used to prevent seizures), antipsychotics (medicine used to treat certain mental health conditions), or other forbidden medicines within one week of starting the study, or within a time frame based on how long the medicine stays in your body (known as its half-life).
  • You have any other medical conditions that might interfere with the study's goals or how it is carried out.
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Investigated drugs

Azetukalner is an experimental medication being tested to see if it can help treat depressive episodes in people living with Bipolar I or Bipolar II disorder.

What is already known about the treatment

  • Placebo

    This is an inactive substance that looks like the actual medicine but contains no active ingredients. It is used in clinical trials to provide a baseline for comparison to see if the real medication truly works. It is typically administered in the same way as the test drug to ensure the study results are fair and unbiased.

  • Azetukalner

    This medication is taken as a capsule by mouth and is currently being studied in late-stage clinical trials to treat depressive episodes in people with bipolar disorder. It belongs to a group of drugs used to manage seizures and brain activity, working by helping to balance the electrical signals and chemical messages in the brain. By calming overactive nerve cells, it helps stabilize mood and reduce the symptoms of depression.

Investigated diseases

Bipolar depression - This condition involves periods of intense sadness or low mood that occur in people diagnosed with bipolar I or bipolar II disorder. It is characterized by symptoms such as a loss of interest in activities, decreased energy, and changes in sleep or appetite. These depressive phases alternate with periods of elevated mood or increased activity. The intensity and duration of these low moods can vary significantly between individuals. The condition is a part of the broader bipolar disorder spectrum.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522775-29-00Protocol codeXPF-010-B301Estimated enrolment379 patientsSponsorXenon Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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