Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 Depressiv...
Detailed Description
The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximatel...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05376150
Start Date
May 19 2022
End Date
October 16 2023
Last Update
September 19 2024
Active Locations (20)
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1
Advanced Research Center
Anaheim, California, United States, 92805
2
Sunwise Clinical Research, LLC
Lafayette, California, United States, 94549
3
California Neuropsychopharmacology Clinical Research Institute
Pico Rivera, California, United States, 90660
4
Artemis Institute for Clinical Research
Riverside, California, United States, 92503