Major Depressive Disorder Research Study

Qualified participants:

• Must be 18-85 years old

• BMI ≤ 40 kg/m² [calculate here]

• Diagnosed with MDD (single or recurrent episode) 

• Must be on a stable dose of antidepressant medication for at least 4 weeks prior to screening  

• Must be registered with a healthcare professional who can confirm the diagnosis and previous treatments received. Confirmation may be noted in the form of email, telephone contact, or written report. 

Answers Must Be NO: 

• If female of childbearing potential, are you currently pregnant, breastfeeding, or planning to become pregnant?   
• Have you ever had gastric bypass or any other bariatric surgery (excluding lap band)?

• Have you previously been or currently diagnosed with ADHD, schizophrenia spectrum, schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, bipolar disorder, or current borderline personality disorder? 

• Do you have a first degree relative with schizophrenia, schizoaffective disorder, or bipolar disorder type 1? 

• Have you had any active suicidal plans in the past 6 months? 

• Do you have a history of substance use disorders (excluding caffeine and tobacco products) within the past 12 months? 

• Have you ever been told you have treatment resistant depression? 

• In the past 14days, have you used any prescription or OTC medicine other than stable chronic dose of antidepressant medications? 

• Do you consume ≥21 units of alcohol weekly? 

• Is there any reason you would have a positive drug test during the screening process? Except for marijuana use if willing to refrain from consumption throughout the trial. 

• In the past 6 months, have you had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD? 

• Are you currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizers? 

• Have you previously used psilocin, or other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times in your life or used any psychedelic at all within the past 12 months? 

• Do you have uncontrolled hypothyroidism or hyperthyroidism? Must be on a stable dose for at least 12 weeks prior to screening. 

• Do you have uncontrolled high blood pressure with systolic BP >139 mmHg or diastolic BP >89 mmHg? Must be on a stable dose of 1 or 2 BP meds for at least 4 weeks prior to screening. 

• Do you have a current or relevant history of brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions)? 

• Do you have any clinically significant ongoing or past physical health issues—such as neurological, cardiovascular, respiratory, gastrointestinal (including dyspepsia or gastroesophageal reflux disease), hepatic, or renal disorder—that might affect your ability to take part in this study, based on your medical history? 

• Do you have any known sensitivity to psilocin? 

• Do you have a history of serotonin syndrome (Excessive serotonin in the brain)?  

• Have you participated in a clinical trial and received medication or investigational drug in the past 12 weeks? 

• In the past 2 weeks have you taken or currently taking; any drugs known to inhibit monoamine oxidase, OTC doses of 5 hydroxytryptophan, or St John’s Wort? 

• In the past 4 weeks, have you donated blood or plasma? 

• Do you have any other medical or surgical condition that would make participation in this study inappropriate or interfere with the trial evaluation, procedure or completion? 

Answers Must Be YES: 

• If engaged in psychotherapy, have you been stable and consistent for at least 12 weeks prior to Screening?  

• Are you willing to refrain from smoking during the dosing visits? 

• If female of childbearing potential, do you agree to use a highly effective method of contraception AND condom during the trial and for 12 weeks after their final dose of trial medication? 

• If female of non-childbearing potential are you;  postmenopausal for at least 12months OR permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy?

• If male, with a female partner of childbearing potential, do you agree to use a condom plus spermicide AND have your partner on a highly effective method of contraception during the trial and for 12 weeks after their final dose of trial medication?   

• Are you willing to consent to audio and video recording of psychological support and dosing sessions? 

• Are you willing to refrain from drugs and alcohol within 48 hours prior to each clinic visit? 

• Are you able to sign consent and comply with all study requirements? 

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 210-714-0067

• If you do not see an available appointment, please call 210-714-0067 for availability.

• Transportation may be available. Call 210-714-0067. Compensation up to $2,000 may be available for time and travel.

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