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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT00833469
Eligibility Criteria:
Inclusion Criteria:
* Women ages 18 to 45 years old
* Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
* Subjects must present within six months of childbirth
* MADRS score \>15
* BAI score \>10
* Subjects will be able to be treated on an outpatient basis
* Subjects will be able to provide written informed consent
Exclusion Criteria:
* Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
* Suicidal ideation with active plan or intent, as determined by the investigator
* Presence of psychotic symptoms or homicidal ideation
* History of mania or hypomania
* Pregnant or breastfeeding
* Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
* Active alcohol/substance abuse currently or within the past year
* Abnormal TSH, severe anemia, or uncontrolled hypertension
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00833469
Study Brief:
Protocol Section:
NCT00833469