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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00222820
Eligibility Criteria:
Inclusion Criteria:
1\. Men and women 2 Age 18-65 3. Currently experiencing an episode of major depression 4. Not currently receiving effective treatment 5. Females of childbearing potential: practicing an acceptable form of birth control 6. Subjects with suicidal ideation are eligible as long as outpatient treatment is deemed safe 7. Willingness and ability to give informed consent.
Exclusion Criteria:
1. History of manic or hypomanic episodes;
2. History of schizophrenia or schizoaffective disorder;
3. Current primary diagnosis of anorexia nervosa or bulimia nervosa;
4. Current psychosis;
5. Drug and/or alcohol dependence or abuse within the past three months (episodic abuse related to mood episodes will not exclude a subject);
6. Antisocial personality disorder (other Axis II disorders will not be exclusionary);
7. Organic affective syndrome;
8. Renal or liver disease;
9. Epilepsy;
10. Cardiovascular disease;
11. Uncontrolled illnesses, including untreated hypertension or unstable endocrine diseases.
12. Women who are or are plan to become pregnant during the course of this study
13. Subjects who require inpatient treatment because of suicidal risk or psychosis
14. Subjects with a well-documented history of an inability to tolerate one of the study treatments or are currently receiving treatment with an effective antidepressant therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00222820
Study Brief:
Protocol Section:
NCT00222820