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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT02122393
Eligibility Criteria:
Inclusion Criteria:
* Women with an infant \> 2 months and \< 8 months of age
* Infant born after a full-term pregnancy
* Infant born with no congenital abnormalities
* Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).
Exclusion Criteria:
* positive serum pregnancy test;
* concurrent psychiatric disorder (excepting co-morbid anxiety);
* recent history of antidepressant usage (within the last month);
* history of major allergy or drug allergy;
* history of substance abuse;
* prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs);
* predisposition to headache, migraine or nausea;
* tobacco habit in excess of 10 cigarettes per day;
* caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day;
* ongoing dental work;
* extreme levels of depression (psychotic);
* suicidal intent;
* participation in any medical trial within the previous three months;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02122393
Study Brief:
Protocol Section:
NCT02122393