A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Recruiting · NCT06775379 · Interventional (participants receive a specific treatment) · Lead sponsor: Xenon Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AzetukalnerPlacebo
What this trial is about
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)
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 or perimenopausal onset; Post traumatic 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 \>1 suicide attempt \>24 years of age.
- 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.
Where it is running
51 locations listed across 21 US states.
- IMA Clinical Research Phoenix - Phoenix, Arizona, United States
- Woodland International Research Group - Little Rock, Arkansas, United States
- Woodland Research Northwest - Rogers, Arkansas, United States
- Behavioral Research Specialists, Llc - Glendale, California, United States
- Marvel Clinical Research - Huntington Beach, California, United States
- Irvine Clinical Research - Irvine, California, United States
- CalNeuro Research Group, Inc. - Los Angeles, California, United States
- Excell Research Inc. - Oceanside, California, United States
- Atp Clinical Research - Orange, California, United States
- Nrc Research Institute - Orange, California, United States
- CenExel CNS-TO (Collaborative Neuroscience Research) - Torrance, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- Kinetic Clinical Research, LLC - West Covina, California, United States
- Mountain View Clinical Research - Denver, Colorado, United States
- Ct Clinical Research Associates - Cromwell, Connecticut, United States
- CNS Clinical Research Group - Coral Springs, Florida, United States
- NeoClinical Research - Hialeah, Florida, United States
- Clinical Neuroscience Solutions, Inc. - Jacksonville, Florida, United States
- Accel Research Sites Lakeland - Lakeland, Florida, United States
- Accel Research Sites - St. Petersburg-Largo - Largo, Florida, United States
- PharmaSouth Research - Miami, Florida, United States
- Quantum Clinical Trials - Miami Beach, Florida, United States
- Harmony Clinical Research Inc - North Miami Beach, Florida, United States
- Clinical Neuroscience Solutions, Inc. - Orlando, Florida, United States
- Combined Research Orlando Phase I-Iv - Orlando, Florida, United States
- Panhandle Research and Medical Clinic - Pensacola, Florida, United States
- Advanced Discovery Research - Atlanta, Georgia, United States
- Synexus - Atlanta - Atlanta, Georgia, United States
- CenExel iResearch - Decatur, Georgia, United States
- Psych Atlanta, Pc - Marietta, Georgia, United States
- Cenexel Iresearch - Savannah - Savannah, Georgia, United States
- Northwest Clinical Trials Inc - Boise, Idaho, United States
- IMA Clinical Research - Chicago, Illinois, United States
- Boston Clinical Trials Llc - Boston, Massachusetts, United States
- ELIXIA - Springfield, Massachusetts, United States
- Tekton Research - St Louis, Missouri, United States
- IMA Clinical Research Las Vegas - Las Vegas, Nevada, United States
- Redbird Research - Las Vegas, Nevada, United States
- IMA Clinical Research - Albuquerque, New Mexico, United States
- Integrative Clinical Trials - Brooklyn, New York, United States
- Richmond Behavioral Associates - Staten Island, New York, United States
- New Hope Clinical Research - Charlotte, North Carolina, United States
- Neuro-Behavioral Clinical Research - North Canton, Ohio, United States
- Pahl Pharmaceutical Professionals Llc - Oklahoma City, Oklahoma, United States
- Lehigh Center For Clinical Research - Allentown, Pennsylvania, United States
- Adams Clinical - Philadelphia - Philadelphia, Pennsylvania, United States
- Clinical Neuroscience Solutions, Inc. - Memphis, Tennessee, United States
- Delricht Research - Plano - Plano, Texas, United States
- Aim Trials, Llc - Plano, Texas, United States
- Grayline Research Center - Wichita Falls, Texas, United States
- Core Clinical Research - Everett, Washington, United States