A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Recruiting · NCT07076407 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
AzetukalnerPlacebo
What this trial is about
X-NOVA3 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
50 locations listed across 18 US states.
- Harmonex Neuroscience Research - Dothan, Alabama, United States
- University of Alabama at Birmingham, Huntsville Regional Medical Campus - Huntsville, Alabama, United States
- Pillar Clinical Research - Bentonville, Arkansas, United States
- SanRo Clinical Research Group - Bryant, Arkansas, United States
- Clinical Innovations Inc - Bellflower, California, United States
- Center for Neurohealth - La Jolla, California, United States
- Artemis Institute for Clinical Research - San Diego, California, United States
- California Neuroscience Research - Sherman Oaks, California, United States
- Pacific Clinical Research Management Group - Upland, California, United States
- Institute of Living - Hartford, Connecticut, United States
- Gulfcoast Clinical Research Center - Fort Myers, Florida, United States
- Sarkis Clinical Trials - Gainesville, Florida, United States
- Equipath Health and Research Tampa Bay, Llc - Riverview, Florida, United States
- Delricht Research - Atlanta, Georgia, United States
- Emory University Brain Health Center - Atlanta, Georgia, United States
- Advanced Quality Medical Research - Orland Park, Illinois, United States
- Smart Trials, LLC - Jefferson, Louisiana, United States
- Pharmasite Research Inc. - Baltimore, Maryland, United States
- Adams Clinical Boston - Boston, Massachusetts, United States
- Activmed Practices & Research, Llc - Methuen - Methuen, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- Vitalix Clinical, Inc - Worcester, Massachusetts, United States
- Psychiatric Care and Research Center - O'Fallon, Missouri, United States
- St. Charles Psychiatric Associates - Midwest Research Group - Saint Charles, Missouri, United States
- Lumina Clinical Research Center - Cherry Hill, New Jersey, United States
- Princeton Medical Institute - Princeton, New Jersey, United States
- Bio Behavioral Health - Toms River, New Jersey, United States
- Bioscience Research, LLC - Mount Kisco, New York, United States
- Fieve Clinical Research, Inc. - New York, New York, United States
- IMA Clinical Research - New York, New York, United States
- Magnolia Clinical Research, Llc - Cary, North Carolina, United States
- Insight Clinical Trials - Independence, Ohio, United States
- Sooner Clinical Research - Oklahoma City, Oklahoma, United States
- Austin Clinical Trial Partners - Austin, Texas, United States
- Boeson Research - Provo, Utah, United States
- Dana Ignjatovićová, spol. s r.o - Banská Bystrica, Slovakia
- Hospital Universitari Vall D'Hebron - Barcelona, Spain
- Charite - Universitatsmedizin Berline - Berlin, Germany
- Centru De Evaluare Si Tratament A Toxicodependentenlor Pentru Tineri Sf. Stelian - Bucharest, Romania
- Clinica Nutrimed Cercetare Sr - Bucharest, Romania
- In Vivo Sp. z.o.o. - Bydgoszcz, Poland
- Institutul Privat De Cercetari Melchisedec (ICPM) Pentru Boli Autoimune Ereditare si Rare - ICPM - Craiova, Romania
- Suomen Terveystalo Oy - Helsinki, Finland
- Clinical Medical Research Sp. z o.o. - Katowice, Poland
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas - Liptovský Mikuláš, Slovakia
- Oulu Mentalcare Oy - Oulu, Finland
- Hospital Universitario Son Espases - Palma de Mallorca, Spain
- Praktyka Lekarska Malgorzata Wojtanowska-Bogacka - Poznan, Poland
- Specjalistyczna Praktyka Lekarska, Filip Rybakowski - Poznan, Poland
- Boehm-Peters PartGmbB - Praxis fur Psychiatrie, Psychotherapie, Neurologie - Rosenheim, Germany