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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Exploring Azetukalner for Bipolar Depression: A Clinical Study

Recruiting
18-74 years
All
Phase 3

This study is to see if a medicine called azetukalner can help adults with bipolar depression feel better. Bipolar depression is when someone with bipolar disorder, which can cause extreme mood changes, feels very sad or down. In this study, some people will get azetukalner, and others will get a placebo, which is a fake treatment that doesn't have any medicine. This helps researchers understand if azetukalner really works.

  • You must be between 18 and 74 years old and have had your first serious depressive episode before age 50.
  • You're not eligible if you have other major depressive disorders or psychiatric conditions or if you've had substance abuse issues recently.
  • The study involves multiple visits and you should not have used certain medications recently.

Participating in this study means you'll help scientists learn more about treating bipolar depression, but you need to make sure you meet all the criteria and are comfortable with the requirements. If you are pregnant or planning to be, you cannot join.

Study details
    Bipolar Disorder
    Bipolar Depression
    Bipolar I Disorder
    Bipolar II Disorder

NCT07172516

Xenon Pharmaceuticals Inc.

7 March 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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