RECRUITING

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

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Conditions

Bipolar DisorderBipolar DepressionBipolar I DisorderBipolar II DisorderBipolarXEN1101Azetukalner

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official 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)

Quick Facts

Study Start:2025-08-08
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07172516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
  2. * Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
  3. * 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).
  4. * Current MDE must has a duration of ≥4 weeks and ≤12 months.
  1. * 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.
  2. * Participant has any nonbipolar psychiatric diagnosis.
  3. * Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
  4. * Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
  5. * Participant has a Young Mania Rating Scale (YMRS) score \>12 points at screening visit or randomization.
  6. * Participant has been hospitalized for mania within the 30 days prior to screening visit.
  7. * 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).
  8. * Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or ≥2 lifetime suicide attempts.
  9. * Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
  10. * Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 2 weeks or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
  11. * Participants with medical conditions that may interfere with the purpose or conduct of the study.
  12. * Participant is pregnant, breastfeeding, or planning to become pregnant.

Contacts and Locations

Study Contact

Xenon Medical Affairs
CONTACT
1-604-484-3300
XenonCares@xenon-pharma.com

Study Locations (Sites)

Woodland International Research Group
Little Rock, Arkansas, 72758
United States
Woodland Research Northwest
Rogers, Arkansas, 72758
United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119
United States
Woodland International Research Group
Wichita Falls, Texas, 76309
United States

Collaborators and Investigators

Sponsor: Xenon Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-08
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-08-08
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Bipolar
  • XEN1101
  • Azetukalner

Additional Relevant MeSH Terms

  • Bipolar Disorder
  • Bipolar Depression
  • Bipolar I Disorder
  • Bipolar II Disorder