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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT00285818
Eligibility Criteria:
Inclusion Criteria:To be considered for participation in the study, subject must meet all of the following criteria:
1\. Meets DSM-IV criteria for Major Depressive Episode without psychotic features.
2\. 18-75 years of age and able to provide legal consent. 3. Referred to Stanford ECT service by treating physician for bilateral electroconvulsive therapy with inpatient hospitalization.
4\. Completed process for consenting to the clinical use of ECT according to California State law.
5\. Females of childbearing potential must be using a double-barrier method of contraception during the study and for 30 days after the study (modified 6-2003) Exclusion Criteria:Subjects will be excluded from participation if they meet any of the following criteria:
1. Treatment with ECT in the 6 months prior to screening.
2. Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening.
3. Use of alcohol or illegal drugs within seven days of randomization or during study.
4. Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by investigator.
5. Use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization.
6. Use of any investigational treatment within 30 days of randomization.
7. Current pregnancy.
8. Current lactation.
9. Previous allergic reaction to mifepristone or drugs of similar chemical structure. (added 6-2003)
10. Use of any oral contraceptives or other drugs that may result in adverse drug-mifepristone interaction effects. A 30-day wash out period for oral contraceptives is required before mifepristone begins.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00285818
Study Brief:
Protocol Section:
NCT00285818