A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
X-NOVA
A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder
1 other identifier
interventional
168
1 country
20
Brief Summary
This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 major-depressive-disorder
Started May 2022
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2023
CompletedSeptember 19, 2024
September 1, 2024
1.3 years
May 11, 2022
September 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
From baseline to end of treatment (Week 6).
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
From randomization to Week 10.
Secondary Outcomes (2)
Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.
From baseline to end of treatment (Week 6).
Change in Beck Anxiety Inventory (BAI) score.
From baseline to end of treatment (Week 6).
Study Arms (3)
XEN1101 10 mg
EXPERIMENTALDuring the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
XEN1101 20 mg
EXPERIMENTALDuring the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
placebo
PLACEBO COMPARATORDuring the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day
Interventions
Eligibility Criteria
You may qualify if:
- Be properly informed of the nature and risks of the study and given written informed consent.
- 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.
You may not qualify if:
- A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders \[including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder\] are allowed).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Advanced Research Center
Anaheim, California, 92805, United States
Sunwise Clinical Research, LLC
Lafayette, California, 94549, United States
California Neuropsychopharmacology Clinical Research Institute
Pico Rivera, California, 90660, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Meridian International Research
Miami, Florida, 33014, United States
Global Medical Institutes (GMI)
Miami, Florida, 33125, United States
CCM Clinical Reseach Group, LLC
Miami, Florida, 33133, United States
i-Research, Atlanta
Decatur, Georgia, 30030, United States
Psych Atlanta, PC
Marietta, Georgia, 30060, United States
iResearch
Savannah, Georgia, 31405, United States
Revive Research Institute, Inc.
Elgin, Illinois, 60123, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Marlton, New Jersey, 08009, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Neurobehavioral Research, Inc. (NBR)
Cedarhurst, New York, 11516, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036, United States
Richard M Weisler and Association
Raleigh, North Carolina, 27609, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
AIM Trials
Plano, Texas, 75093, United States
Related Publications (1)
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.
PMID: 40423966DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Xenon Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 17, 2022
Study Start
May 19, 2022
Primary Completion
September 18, 2023
Study Completion
October 16, 2023
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share