Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Xenon Pharmaceuticals Inc.
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
