Major Depression Study for Adults

Azetukalner vs Placebo for MDD

$100 per completed visit
 
  • Azetukalner vs Placebo – This is a double blind study in which subjects are randomly placed on either Azetukalner or Placebo. Dr. Handal will be able to find out what medication the subject is on in case of an emergency.
  • This is a 6-week treatment period with the option of an open-label phase.   
  • Participants are reimbursed $100 for their time and travel at the end of each completed visit.
  • Must be between the ages of 19-74
  • First major depressive episode must be prior to age 50.
  • Current depressive episode of at least 6 weeks and not exceeding 24 months in duration before screening. 
  • BMI of 40 kg or less.
  • Psychotherapy for MDD is allowed if initiated or terminated within 3 months before screening.
  • Periodic use of marijuana, cannabinoids, and/or other derivatives (3 times or less per week) is not exclusionary.  
  • Has a primary diagnosis of a mood disorder other than MDD. 
  • History of: MDD with psychotic or catatonic features, MDD w/ mixed features, OCD, bipolar, schizophrenia, schizoaffective disorder, or other psychotic illness.
  • Current diagnosis of: MDD w/ seasonal pattern, depression w/ peripartum onset,  PTSD, panic disorder and/or agoraphobia, antisocial or borderline personality disorder (or presence of traits).  
  •  ADHD treated w/ a psychostimulant, diagnosed during the current MDE, or with unstable symptoms.
  • Alcohol or substance use disorder within 12 months of screening.  Periodic use of marijuana, cannabinoids, and/or other derivatives (3 times or less per week) is not exclusionary.  
  •  History of non-response to Electroconvulsive therapy (ECT) in the past 10 years.
  • Received TMS during the current MDE. 
  • Active suicidal plan/intent in the past 6mo.  Suicidal behavior in the past 2 years.  Non-suicidal self-harm behavior in the past 12 mo. 
  • History of seizures except for febrile seizures that resolved by age 5. 
  • Clinically significant chronic pain, treated or untreated, during the current MDE.
  • An eating disorder in the past 12 mo.
  • History of cancer in the past 2 years that is likely to recur at any point during the study. 
  • Antidepressants,  antipsychotics,  anticonvulsants, mood stabilizers, lithium, stimulants, opioids w/in 2 weeks (4 weeks for fluoxetine) prior to randomization.  
  • History of non-response to 2 or more antidepressants at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current depressive episode. 
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