A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
NCT ID: NCT07172516
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-08-08
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Azetukalner
Azetukalner 20 mg
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
Placebo
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Interventions
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Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
74 Years
ALL
No
Sponsors
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Xenon Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Clinical Innovations Inc
Bellflower, California, United States
ProScience Research Group
Culver City, California, United States
ATP Clinical Research
Orange, California, United States
NRC Research Institute
Orange, California, United States
Clinical Innovations Inc
Riverside, California, United States
PharmaSouth Research, LLC
Coral Gables, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Synexus Clinical Research, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
Denali Health Atlanta, LLC
Stone Mountain, Georgia, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, United States
Neurobehavioral Research Inc
Cedarhurst, New York, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Grayline Research Center
Wichita Falls, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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XPF-010-B301
Identifier Type: -
Identifier Source: org_study_id