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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT01559857
Eligibility Criteria:
Inclusion Criteria:
* Age between 20 and 65 years
* BMI between 25 and 35
* Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS)
* Depression severity as defined by score of \< 12 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months
* Willingness to sign human subjects consent form
Exclusion Criteria:
* Diagnosis of possible or probable cognitive impairment
* For women only: pregnancy, breastfeeding
* Personal history of Type I or Type II diabetes
* Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year
* Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure \> 170 or diastolic blood pressures \> 100)
* Current drug or alcohol abuse
* History of neurological disorder, e.g. multiple sclerosis, stroke etc
* Use of any drug that may significantly affect psychometric testing or the insulin testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01559857
Study Brief:
Protocol Section:
NCT01559857