Clinical trial NCT06775379: A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Antidepressant
XEN1101
Azetukalner
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)


Eligibility criteria: Key Inclusion Criteria:

* Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age
* Body Mass Index (BMI) ≤40 kg/m2
* Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)
* Participant's current MDE has a duration of ≥6 weeks and ≤24 months.

Key Exclusion Criteria:

* Participant has a primary diagnosis of a mood disorder other than MDD.
* Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder.
* Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum onset; Posttraumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator.
* Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening.
* Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or ≥2 lifetime suicide attempts.
* Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening.
* Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization.
* Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ).
* Participants with medical conditions that may interfere with the purpose or conduct of the study
* Participant is pregnant, breastfeeding, or planning to become pregnant.

Primary outcomes:
measure: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) score at Week 6
timeFrame: Baseline to Week 6
measure: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 1
timeFrame: Baseline to Week 1
measure: Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: IMA Clinical Research Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Oceanside
country: United States
facility: Excell Research Inc.
state: California
city: Torrance
country: United States
facility: CenExel CNS-TO (Collaborative Neuroscience Research)
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research
state: California
city: Hialeah
country: United States
facility: NeoClinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites Lakeland
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Miami
country: United States
facility: PharmaSouth Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Pensacola
country: United States
facility: Panhandle Research and Medical Clinic
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center Inc.
state: Illinois
city: Las Vegas
country: United States
facility: IMA Clinical Research Las Vegas
state: Nevada
city: Albuquerque
country: United States
facility: IMA Clinical Research
state: New Mexico
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
References: