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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT06594406
Eligibility Criteria:
Inclusion Criteria for depression:
* Adults age 18-60 years inclusive.
* Current diagnosis of major depression disorder (MDD) identified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5).
* Current Hamilton Depression Scale 17 score of \> 16.
* BMI (body Mass Index) between 18 and 28 kg/m²
* Right-handed
Exclusion Criteria:
* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5.
* History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
* History of seizure disorder
* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
* Previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome
* Antibiotic use in last 30 days
* Probiotics use in last 30 days
* Positive pregnancy test
* Breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06594406
Study Brief:
Protocol Section:
NCT06594406