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

NCT07172516 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: XPF-010-B301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 28

Brief Summary

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).

Conditions

Bipolar Disorder; Bipolar Depression; Bipolar I Disorder; Bipolar II Disorder

Keywords

Bipolar; XEN1101; Azetukalner

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 6

Secondary Outcomes (3)

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

  Baseline to Week 6

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

  Baseline to Week 1

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

  Baseline to Week 6

Study Arms (2)

Azetukalner

EXPERIMENTAL

Azetukalner 20 mg

Drug: Azetukalner

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Azetukalner DRUG

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

Also known as: XEN1101

Azetukalner

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (28)

Noble Clinical Research

Tucson, Arizona, 85704, United States

RECRUITING

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

RECRUITING

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

RECRUITING

Clinical Innovations Inc

Bellflower, California, 90706, United States

RECRUITING

ProScience Research Group

Culver City, California, 90230, United States

RECRUITING

ATP Clinical Research

Orange, California, 92866, United States

RECRUITING

NRC Research Institute

Orange, California, 92868, United States

RECRUITING

Clinical Innovations Inc

Riverside, California, 92506, United States

RECRUITING

PharmaSouth Research, LLC

Coral Gables, Florida, 33146, United States

RECRUITING

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

RECRUITING

Central Miami Medical Institute

Miami, Florida, 33125, United States

RECRUITING

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

RECRUITING

Synexus Clinical Research, Inc.

Atlanta, Georgia, 30328, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch

Decatur, Georgia, 30030, United States

RECRUITING

Denali Health Atlanta, LLC

Stone Mountain, Georgia, 30083, United States

RECRUITING

Advanced Quality Medical Research

Orland Park, Illinois, 60462, United States

RECRUITING

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

RECRUITING

Redbird Clinical Research, LLC

Las Vegas, Nevada, 89119, United States

RECRUITING

Lumina Clinical Research Center

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

RECRUITING

Neurobehavioral Research Inc

Cedarhurst, New York, 11516, United States

RECRUITING

DelRicht Research

Charlotte, North Carolina, 28210, United States

RECRUITING

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103, United States

RECRUITING

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

RECRUITING

Elevate Synapsis, LLC

Atascocita, Texas, 77346, United States

RECRUITING

Grayline Research Center

Wichita Falls, Texas, 76309, United States

RECRUITING

Eastside Therapeutics Resources, INC dba Core Clinical Research

Everett, Washington, 98201, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

XEN1101

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Xenon Medical Affairs

CONTACT

1-604-484-3300; XenonCares@xenon-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)