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NCT Number: NCT07172516

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

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

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Key information

Conditions

Bipolar Disorder Bipolar Depression Bipolar I Disorder Bipolar II Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Noble Clinical Research, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
  • Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • Current MDE must has a duration of ≥4 weeks and ≤12 months.

Key Exclusion Criteria:

  • Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
  • Participant has any nonbipolar psychiatric diagnosis.
  • Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
  • Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
  • Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization.
  • Participant has been hospitalized for mania within the 30 days prior to screening visit.
  • Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).
  • Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.
  • Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
  • Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
  • Participants with medical conditions that may interfere with the purpose or conduct of the study.
  • Participant is pregnant, breastfeeding, or planning to become pregnant.

Treatment and study plan

Azetukalner

Drug

Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks

Other names: XEN1101

Placebo

Drug

Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Primary outcomes

  1. Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.

    Time frame: Baseline to Week 6

Secondary outcomes

  1. Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6.

    Time frame: Baseline to Week 6

  2. Change from baseline in the MADRS total score at Week 1.

    Time frame: Baseline to Week 1

  3. Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.

    Time frame: Baseline to Week 6

Study contacts

Contact information is provided by the study sponsor or research team.

Xenon Medical Affairs

CONTACT

[email protected]

1-604-484-3300

Sponsors and collaborators

Lead sponsor

Xenon Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Acronym: X-CEED

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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