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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT00102492
Eligibility Criteria:
Inclusion criteria:
* Subjects must have the ability to comprehend the key components of the consent form.
* Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
* If female, subjects must be practicing an acceptable method of birth control.
* Subjects must have rating scores as outlined.
Exclusion criteria:
* Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
* Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
* Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
* Subjects with an unstable medical disorder.
* If female, pregnant or lactating.
* Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00102492
Study Brief:
Protocol Section:
NCT00102492