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 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT01098318
Eligibility Criteria:
Inclusion Criteria:
* Men and women (all races and ethnicity) ≥ 18 years old
* DSM IV Axis I diagnosis of mild to moderate Major Depressive Disorder
* Baseline CGI/S rating of 3 ('mild') or 4 ('moderate')
* Baseline Hamilton Depression Rating score ≥ 10
* Not receiving other antidepressant therapy
* Able to provide signed informed consent
Exclusion Criteria:
* Patients \< 18 years old
* Current primary DSM IV Axis I diagnosis other than Major Depressive Disorder
* CGI/S rating of 5 ('marked'), 6 ('severe') or 7 ('very severe')
* Actively suicidal or requiring hospitalization
* Uncontrolled medical condition
* Pregnant or nursing women
* Women of child-bearing potential not using a medically acceptable form of contraception
* Concurrent use of herbal remedies or mineral supplements \[Note: Use of mineral supplements prescribed for medical purposes (e.g., osteoporosis) will not be excluded\]
* Current use of chemotherapy or other medication (e.g., interferon) known to produce fatigue or mood changes
* Known sensitivity to R. rosea or sertraline
* History of non-response to sertraline in the current depressive episode
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01098318
Study Brief:
Protocol Section:
NCT01098318