Basic Criteria:
- Be diagnosed with Major Depressive Disorder (MDD)
- Be taking a stable dose of antidepressant medication for at least one month
Answers Must Be No:
- If female of childbearing potential, are you pregnant, breastfeeding, or planning on becoming pregnant?
- Do you have a current or previous diagnosis of Schizophrenia or other severe psychotic disorders (such as bipolar disorder, schizoaffective disorder, brief psychotic disorder, or borderline personality disorder)?
- Do you have any first-degree relatives with a history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1?
- Have you had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months?
- Are you currently receiving treatment or been treated in the past 2 weeks with a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, trazodone, moclobemide, buspirone, an antipsychotic, mood stabilizers or St John’s Wart?
- Do you have Uncontrolled High Blood Pressure, Hypothyroidism or Hyperthyroidism that has not been managed by stable medication for 3+ months?
- Have you been treated with Ketamine in the past year?
- Do you currently or have you previously had a brain disorder (e.g. epilepsy, seizures, intracranial hypertension, intracranial bleed, aneurysmal disease, or another medical condition associated with seizures or convulsions)?
- Have you ever had Serotonin Syndrome?
- Do you have a history of substance use disorder in the past year?
Answers Must Be Yes
- Have you been diagnosed with Major Depressive Disorder (MDD)?
- Are you able to pass an alcohol or drug test at screening?
- Do you have a BMI of 40 kg/m2 or less? [Calculate here]
- If you are 60 years or older, did your first MDD episode occur prior to turning 60?
- Have you been taking a stable dose of antidepressant medication for at least 1 month?
- If female of childbearing potential and sexually active, are you willing to use at least one highly effective method of contraception in addition to the use of condoms?
- If male and sexually active with a female of childbearing potential, are you willing to use condoms AND spermicide throughout the study?
Additional criteria will apply
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