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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01327404
Eligibility Criteria:
Inclusion Criteria:
* Age: 30 to 80 years old
* Diagnosis of type 2 diabetes
* Diagnosis of major depressive disorder using standard diagnostic and statistical manual (DSM) criteria
* Score of 15 or greater on the 17-item Hamilton Depression rating scale
* Mini Mental Status Exam score of 24 or greater
* No evidence of clinical dementia or any other clinical brain disorder
* Free of psychotropic/psychoactive medications for at least 2 weeks
* First episode of depression diagnosed either after or around the time type 2 diabetes was diagnosed since we are interested in the relationship between the cerebrovascular effect of diabetes and the pathophysiology of major depression
Exclusion Criteria:
* Presence of dementia or any other clinical brain disorder (Parkinson's, Alzheimer's)
* Mini Mental Status Exam score of less than 24
* Unstable medical illness (grade 4 on the Cumulative Illness Rating Scale)
* Presence of any metallic implant that would preclude an MRI scan (pacemaker, etc.)
* Concurrent Axis 1 disorder (schizophrenia, bipolar)
* Use of atypical neuroleptics for the current episode and/or strong clinical suspicion that the diabetes is secondary to the use of atypical neuroleptics;
* Recurrent major depression, operationally defined as two or more, well-characterized episodes of depression, prior to the onset/diagnosis of diabetes
* Seizure disorder
* Stroke/Transient Ischemic Attack
* Central nervous system disorder (multiple sclerosis)
* Trauma to head/Loss of Consciousness
* Claustrophobia
* Eating disorder (anorexia, bulimia)
* Weight of over 350 pounds
* Learning disorder (dyslexia, ADHD)
* Psychosis, panic or anxiety disorder outside the context of depression
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT01327404
Study Brief:
Protocol Section:
NCT01327404