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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT03202095
Eligibility Criteria:
Inclusion Criteria:
* Current diagnosis of Major Depressive Disorder identified by the SCID-5-RV
* Current HAM-D score of \> 16
* Current type 2 diabetes (as confirmed by clinical history and baseline glycosylated hemoglobin percentage (HgA1c) \> 6.5.
* Diabetes type II present for at least one year
Exclusion Criteria:
* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-RV
* History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
* Electrolyte disturbance (hypokalemia, hyperkalemia, hyponatremia, or hypernatremia) on screening basic metabolic panel
* History of cardiac disease or QTc \>500ms on screening EKG
* History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
* History of seizure disorder
* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
* Positive pregnancy test
* Breastfeeding
* Contraindication to an MRI scan
* Current incarceration
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT03202095
Study Brief:
Protocol Section:
NCT03202095