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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT00360256
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between ages 18 and 65 of any ethnic background
* Diagnosis of major depressive disorder, dysthymic disorder or depressive disorder NOS.
* Experienced side effects on antidepressant metabolized by CYP 2D6 and 2C19 that required discontinuation of treatment
* Experienced side effects from 2 or more antidepressants metabolized by CYP 2D6 and 2C19
Exclusion Criteria:
Exclusion criteria:
* Patients with diagnosis of bipolar disorder or any anxiety disorder. We decided to exclude patients with these diagnoses, due to the fact that antidepressants may exacerbate symptoms of bipolar and anxiety disorders and there is a risk that these symptoms can be attributed instead to antidepressant adverse effects.
* Patients taking inhibitors of drugs metabolized by CYP 2D6 and 2C19
* Patients who are non-English speaking: the English version of the UKU side effects rating scale will be used. The rating of side effects depends on the patient interview and the information found in the medical record. To appreciate the extent of the side effects, the rater and the research participant must be speaking the same language. Thus, to include non-English speaking participants, both the research and the clinical staff would need to be fluently bilingual, which is not the case at MCG inpatient and outpatient treatment facilities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00360256
Study Brief:
Protocol Section:
NCT00360256