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:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT00208702
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
* Primary diagnosis of unipolar Major Depressive Disorder
* HAM-D (21 item) score \>18
Exclusion Criteria:
* Alcohol abuse or alcohol dependence within the past year.
* Psychoactive substance abuse or dependence within the past year.
* Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
* ECT within the past 6 months.
* Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
* Serious and unstable medical illnesses.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00208702
Study Brief:
Protocol Section:
NCT00208702