Phase 1 Depression and Anxiety Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men and women between the ages of 21 and 65
• People with a body weight considered in the healthy to moderately overweight range (BMI between 18 and 35)
• People willing to avoid taking any medications not approved by the study doctor during the trial
• People willing to avoid alcohol and recreational drugs during the trial
• People who return a negative drug test result
• People willing and able to avoid smoking during each test session
• Women who are able to become pregnant and are sexually active must be willing to use an effective form of contraception
• People willing to arrange transport to and from testing sessions rather than driving themselves

For people with Major Depressive Disorder (MDD), these additional criteria apply:

• People who have been diagnosed with Major Depressive Disorder
• People who have not had a satisfactory response to antidepressant medications
• People either currently receiving treatment for depression from a clinician and willing to continue that treatment throughout the study, or people not currently in treatment
• People willing to allow the research team to communicate with their mental health provider
• People whose mental health clinician supports their participation in the trial

For healthy volunteers, these additional criteria apply:

• People with no current psychiatric disorder (excluding nicotine or caffeine use)
• People who have not taken psychiatric medication for more than 3 months at any point in their life

Who may not be able to join:

• People taking medications that could significantly interfere with the study medications
• People with cognitive difficulties that could affect their ability to participate
• People with an alcohol or substance use disorder
• People with any history of a hallucinogen use disorder
• People who regularly use or have misused hallucinogens
• People with a history of bad reactions to drugs that alter perception
• People with significant blood pressure problems
• People who are pregnant or currently breastfeeding
• People with unstable medical conditions
• People with significant heart or cardiovascular disease
• People with significantly abnormal laboratory test results
• People with a history of serotonin syndrome (a serious reaction involving certain medications)

For people with MDD, these additional exclusions apply:

• People whose primary psychiatric diagnosis is something other than MDD
• People with a medical condition that would make participation unsuitable (confirm with trial site)

For healthy volunteers, these additional exclusions apply:

• People who currently have a psychiatric disorder (excluding nicotine or caffeine use)
• People with a close family history of serious mental illness such as schizophrenia or bipolar disorder

Important: Always verify eligibility with the trial site directly before applying.