Phase 4 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:

For young people with anxiety:

• A parent, guardian, or legal representative, as well as the young person themselves, must provide written agreement to take part
• The young person and their parent, guardian, or legal representative must be fluent in English
• The young person must be between 8 and 17 years old (inclusive) at the first visit, and have a parent, guardian, or legal representative
• The young person must have a diagnosis of generalised anxiety disorder, social anxiety disorder, and/or separation anxiety disorder, confirmed using a standard diagnostic interview, with no lifetime history of mania, OCD, or significant trauma exposure
• The young person must score 15 or higher on the PARS anxiety scale at both the first and second visits (confirm with trial site for details on this scale)
• A caregiver must be willing to monitor the young person's safety, provide information about their condition, and oversee the taking of the study medication
• The young person must have no significant abnormalities found during a physical examination
• Females must have a negative pregnancy test at the first visit
• Sexually active participants must use an approved reliable form of contraception throughout the study and for 30 days after it ends — approved methods include surgical sterilisation, oral contraceptives, contraceptive skin patches, depot injections, vaginal rings, implants, an intrauterine device, or a diaphragm used with a condom

For healthy volunteers (comparison group):

• A parent, guardian, or legal representative, as well as the young person themselves, must provide written agreement to take part
• The young person and their parent, guardian, or legal representative must be fluent in English
• The young person must be between 8 and 17 years old (inclusive) at the first visit, and have a parent, guardian, or legal representative
• The young person must have no history of any diagnosable mental health condition (a history of nicotine use disorder or adjustment disorder is permitted), confirmed using a standard diagnostic interview
• A caregiver must be willing to monitor the young person's safety and provide information about their condition
• The young person must have no significant abnormalities found during a physical examination, and females must have a negative pregnancy test at screening
• The young person must have a negative urine drug screen at screening
• No close (first-degree) family members of the young person may have a history of mood disorders, anxiety disorders, or psychotic disorders

Who may not be able to join:

• People who have an additional diagnosis of a mood disorder (other than persistent depressive disorder or unspecified depressive disorder), an eating disorder, bipolar disorder, or a psychotic disorder alongside their anxiety diagnosis
• People who have taken SSRI medications within 12 weeks before the second visit, or who are currently taking any medication affecting the brain and nervous system that takes a long time to leave the body (confirm with trial site)
• People with a significant history of neurological illness, serious medical illness, or a head injury that caused loss of consciousness for 5 minutes or more
• People with a lifetime history of mania, OCD, or significant trauma exposure
• People with a known allergy or sensitivity to sertraline
• People with a diagnosis of intellectual disability or a recorded IQ below 70
• People with a history of alcohol or substance use disorder, or any substance misuse in the past 6 months (nicotine dependence is permitted)
• People who have been in psychotherapy for less than 2 months before the second visit
• Females who are pregnant, breastfeeding, or lactating
• People who live more than 100 miles from the University of Cincinnati, or more than 90 minutes from the participating site, or who are unable to attend follow-up visits
• People who are unable to swallow capsules
• People who the trial investigator considers to be at current risk of suicide, or whose participation could pose a safety risk or affect the reliability of study results

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