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 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT06080932
Eligibility Criteria:
Inclusion Criteria:
* OSU students (age 18-30 years at the time of enrollment) with confirmed major depressive disorder as determined by SCID-5 diagnosis at baseline testing.
* Currently engaged in counseling treatment for depression at CCS
* Available for a 12-week period and indicate willingness and ability to eat KD foods as prescribed
Exclusion Criteria:
* Disordered eating, as evidenced by meeting criteria for Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Eating Disorder, Unspecified Eating Disorder, or Avoidant Restrictive Eating Disorder during the SCID-5 interview at baseline testing.
* Substantial imminent risk of suicide as assessed during the SCID-5 interview.
* Body mass index (BMI) \< 20 kg/m2
* Habitual consumption of a structured low-carbohydrate diet in the last 6-months
* Gastrointestinal disorders or allergies that would prevent adherence to prescribed diets
* Alcohol consumption in excess of 3 drinks/daily or 14 drinks/weekly
* Diagnosed diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or use of diabetic medications other than metformin
* Inability to access or prepare appropriate KD foods/meals
* Pregnant, lactating, or planning on becoming pregnant during the study
* Unwilling to perform finger-stick blood testing or continuous glucose/ketone monitoring
Exclusion for optional MRI:
• The CCBBI screening form (https://redcap.osumc.edu/redcap/surveys/?s=N3XJ4WC7T9) will be used to assess MRI eligibility. Endorsement of items that contraindicate MRI will serve as exclusion criteria (pacemaker, stint, claustrophobia, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT06080932
Study Brief:
Protocol Section:
NCT06080932