A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
NCT ID: NCT05376150
Last Updated: 2024-09-19
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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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2022-05-19
2023-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XEN1101 10 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
XEN1101 10 mg
XEN1101 oral capsule
XEN1101 20 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
XEN1101 20 mg
XEN1101 oral capsule
placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day
Placebo
Placebo capsule
Interventions
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XEN1101 10 mg
XEN1101 oral capsule
XEN1101 20 mg
XEN1101 oral capsule
Placebo
Placebo capsule
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
* Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
* Current MDE duration ≥2 months and \<24 months at the time of screening.
* Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.
* Score ≥20 on the SHAPS at screening and on Day1.
* Must be willing to comply with the study protocol for the full term of the study.
Exclusion Criteria
* Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
* History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
* History of non-response to \>1 antidepressant drug due to lack of efficacy in the current MDE.
* Failing \>3 antidepressant drug trials, for any reason, in the current MDE.
* History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
* Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
* Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
* Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
18 Years
65 Years
ALL
No
Sponsors
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Xenon Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Xenon Pharmaceuticals Inc.
Locations
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Advanced Research Center
Anaheim, California, United States
Sunwise Clinical Research, LLC
Lafayette, California, United States
California Neuropsychopharmacology Clinical Research Institute
Pico Rivera, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Meridian International Research
Miami, Florida, United States
Global Medical Institutes (GMI)
Miami, Florida, United States
CCM Clinical Reseach Group, LLC
Miami, Florida, United States
i-Research, Atlanta
Decatur, Georgia, United States
Psych Atlanta, PC
Marietta, Georgia, United States
iResearch
Savannah, Georgia, United States
Revive Research Institute, Inc.
Elgin, Illinois, United States
Altea Research
Las Vegas, Nevada, United States
Hassman Research Institute
Marlton, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Neurobehavioral Research, Inc. (NBR)
Cedarhurst, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
Richard M Weisler and Association
Raleigh, North Carolina, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
AIM Trials
Plano, Texas, United States
Countries
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References
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Butterfield NN, Luzon Rosenblut C, Fava M, Correll CU, Rothschild AJ, Murrough JW, Mathew SJ, Beatch GN, Grayson C, Harden C, Qian J, McIntosh J, Namdari R, Kenney C. Azetukalner, a Novel KV7 Potassium Channel Opener, in Adults With Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2514278. doi: 10.1001/jamanetworkopen.2025.14278.
Other Identifiers
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XPF-008-204
Identifier Type: -
Identifier Source: org_study_id
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