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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Hospital General Universitario Gregorio Maranon Madrid Spain
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Medical Center Saint Naum EOOD Sofia Bulgaria
Instytut Psychiatrii I Neurologii Warsaw Poland
Hospital Alvaro Cunqueiro Vigo Spain
Servei De Salut De Les Illes Balears Palma Spain
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD Kazanlak Bulgaria
Instituto De Investigaciones Neuropsiquiatricas Doctor Lopez Ibor S.A. Madrid Spain
Clinic BBP Bożena Pawełczyk Katowice Poland
Cplovtw Bzjvi Kgcilwyprog Pfmcnjgv Spx z oieb Gdansk Poland
Cvmqim Flz Mxboum Hsxxdz Vpvlrx Errx Vratsa Bulgaria
Uexscpmmqlynqpemtvkic Mxhzkajk Abs Munster Germany
Gxrngr Uugnjgvvll Ffnwzeovw Frankfurt Germany
Suett Pbrnaskofpd Htlkyptz &tqpkok Lvhjvr Lovech Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
31.05.2026
Germany Germany
Not yet recruiting
31.05.2026
Poland Poland
Not yet recruiting
31.05.2026
Spain Spain
Recruiting
31.05.2026

Trial locations

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.

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 ID:
2025-522775-29-00
Protocol code:
XPF-010-B301
NCT ID:
NCT07172516
Trial Phase:
Therapeutic confirmatory (Phase III)

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