Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT05531604
Eligibility Criteria:
Inclusion Criteria:
1. AN-Restricting (AN-R) Group
Inclusion criteria:
1. Females from any racial or ethnic background
2. Ages between 12 and 22 years
3. Meet DSM-5 criteria for AN - restricting subtype
4. Medically stable designated by their physician in the past month (having any of the following measurements taken by a physician or nurse within the past month preceding the telephone screen: (i) orthostasis: drop in systolic blood pressure \> 20 mm Hg or diastolic blood pressure \> 10 mm Hg, or an increase in heart rate (HR) \> 20 bpm upon standing for 3 minutes after lying down; (ii) resting HR \<45; or (iii) resting blood pressure of \<80 mm Hg systolic or \<50 mm Hg diastolic 99. Prospective participants who do not meet the medical instability criteria and otherwise pass the telephone screen, will be invited to proceed to the consent process. If they have not had these measurements done in the month prior, we will encourage them to visit their doctor or nurse to have these done and then to recontact us with the results ):
5. BP and pulse measured at the day of the scan by the investigators
* Heart rate ≥ 45 at rest
* Resting blood pressure of ≥80 mm Hg systolic and ≥50 mm Hg diastolic
* Lying and standing (after 3 min.) BP drop of ≤20 systolic and ≤10 diastolic and increase in HR ≤20 bpm
6. Not taking psychiatric medications or taking serotonin-reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor medications at stable doses
2. History of AN-Restricting Group:
Inclusion criteria:
1. Females from any racial or ethnic background
2. Ages between 12 and 22 years
3. EDE-Q ≤ 2 (puts them within 1 standard deviation \[SD\] of community norms and lower than 1 SD from clinical norms for female AN-R)
4. History of AN - meeting full criteria, diagnosed by a licensed clinician
5. Not taking psychiatric medications or taking serotonin-reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor medications at stable doses
3. Healthy controls:
Inclusion criteria:
1. Healthy females from any racial or ethnic background
2. Ages 12-22 years
Exclusion Criteria:
* AN-R and History of AN-R groups:
1. Antipsychotic medications
2. Change in dose of psychotropic medication over the previous 4 weeks
3. Current psychotic disorder
Healthy controls:
1. Any current Axis I disorder
2. Eating Disorder Examination Questionnaire score greater than established community norms (\>2)
3. Met criteria for AN (in the past or present)
All:
1. Neurological disorder
2. Infants or children of their own
3. Pregnancy
4. Current risk of suicide with a plan and intent
5. Ferromagnetic metal implantations or devices (electronic implants or devices, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
22 Years
Study:
NCT05531604
Study Brief:
Protocol Section:
NCT05531604