Clinical trial NCT05376150: A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
Official title: A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Potassium channel
Depression
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 approximately 14 weeks.

Eligibility criteria: Key Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
timeFrame: From baseline to end of treatment (Week 6).
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
timeFrame: From randomization to Week 10.
Secondary outcomes:
measure: Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.
timeFrame: From baseline to end of treatment (Week 6).
measure: Change in Beck Anxiety Inventory (BAI) score.
timeFrame: From baseline to end of treatment (Week 6).
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research, LLC
state: California
city: Pico Rivera
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Miami
country: United States
facility: Meridian International Research
state: Florida
city: Miami
country: United States
facility: Global Medical Institutes (GMI)
state: Florida
city: Miami
country: United States
facility: CCM Clinical Reseach Group, LLC
state: Florida
city: Decatur
country: United States
facility: i-Research, Atlanta
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta, PC
state: Georgia
city: Savannah
country: United States
facility: iResearch
state: Georgia
city: Elgin
country: United States
facility: Revive Research Institute, Inc.
state: Illinois
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc. (NBR)
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: Raleigh
country: United States
facility: Richard M Weisler and Association
state: North Carolina
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
Study officials:
affiliation: Xenon Pharmaceuticals Inc.
name: Study Director
role: STUDY_DIRECTOR
References: