Early Phase 1 Depression and Anxiety Trial, Recruiting

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

Who might be able to join this trial:

• People aged 15 to 24 years (both female and male)
• People who are fluent in English
• People who have access to a smartphone, tablet, or computer that can run the program "Zoom" for remote appointments
• People who have been diagnosed with a primary depressive disorder according to DSM-5 criteria — this includes Major Depressive Disorder, Persistent Depressive Disorder, or Other Specified Depressive Disorder — confirmed through a structured diagnostic interview
• People who are currently under the care of a primary care doctor and/or a mental health professional
• People who have been taking an SSRI antidepressant medication for at least 8 weeks
• People whose depression symptom score on the BDI-II questionnaire is greater than 13 (indicating at least mild depression)

Who may not be able to join:

• People who have a current diagnosis of another mental health condition under DSM-5, unless it is an anxiety disorder or ADHD and the depressive disorder is the main diagnosis
• People currently being treated with stimulant medication for ADHD, unless the dosage has been stable and there are no plans to change it for at least 8 weeks
• People who have a current diagnosis of a personality disorder, as assessed by a structured clinical interview
• People who have taken oral probiotic supplements in the month before the phone screening
• People who have taken oral or intravenous (IV) antibiotic medication in the month before the phone screening
• People who have eaten fermented foods (such as yogurt or kombucha) in the month before the phone screening
• People who have taken oral antioxidant or omega-3 supplements within 6 weeks before the phone screening
• People who currently drink more than 2 alcoholic drinks per week
• People who have smoked more than 5 cigarettes in the last 6 months, or have used a pipe or hookah even once in the last month
• People who have plans to make significant changes to their diet or lifestyle
• People who have a weakened immune system
• People who have allergies to milk, soy, or yeast
• People who have not yet reached a certain stage of physical development known as Tanner Stage 3 (confirm with trial site)
• People who are currently experiencing active thoughts of suicide that would require hospital admission, or who have a specific plan or intention to attempt suicide, as assessed by a standardised scale
• People who have made a suicide attempt within the past 6 months that required hospitalisation or an emergency department visit
• People whose depression has not responded to two or more adequate treatment attempts with two different first-line SSRI antidepressant medications
• People who are unable to have an MRI scan for any reason (for example, having metal braces)
• People who are currently pregnant or who plan to become pregnant during the study period; people of reproductive capability who are eligible to participate will be asked to use at least one approved method of contraception until their second MRI scan is completed

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