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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT03623620
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women
* Ages 18 or older
* History of recurrent major depression prior to pregnancy (at least 2 prior episodes, one of which may be currently treated)
* Euthymic or with residual symptoms (PHQ-9 ≤ 9)
* No depressive relapse since last menstrual period
* Currently or recently received antidepressants (within the three months prior to last menstrual period)
* Presence of ongoing community provider
Exclusion Criteria:
* Diagnosis of bipolar or psychotic disorder
* Active mania, psychosis, or substance abuse (within the last 6 months)
* Immediate risk of self-harm
* Non-English speaking
Inclusion and exclusion criteria for the participants in the supplemental arms of the study differ from the main study and are as follows:
Arm 1 Aim 1a
Inclusion Criteria:
* Pregnant women (prior to 16 weeks gestation)
* Age 18 or older
* Presence of an ongoing community prescriber / provider
* Suicidal ideation as noted by item #9 of the PHQ-9
* History of recurrent depression, dysthymia or subsyndromal depression
Exclusion Criteria:
* Diagnosis of bipolar or psychotic disorder
* Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
* Non-English speaking
Arm 1 Aim 1b
Inclusion Criteria:
* Age 18 or older
* Current prenatal healthcare provider of a participant enrolled in Arm 1 Aim 1a
Exclusion Criteria:
* Non-English speaking
Arm 1 Aim 1c
Inclusion Criteria:
* Pregnant women
* Age 18 or older
* Self-reported history of major depressive disorder
* Suicidal ideation as noted by item #9 of the PHQ-9
Exclusion Criteria:
* Non-English speaking
Arm 2
Inclusion Criteria:
* Pregnant women (prior to 16 weeks gestation)
* Age 18 or older
* History of recurrent major depression prior to pregnancy (at least two prior episodes, one of which may be currently treated)
* Euthymic or with residual symptoms (PHQ-9 \</=9)
* Presence of an ongoing community prescriber / provider
* Current suicidal ideation as noted by item #9 of the PHQ-9 or past suicidal ideation as noted by item A3g on the MINI mood module
Exclusion Criteria:
* Diagnosis of bipolar or psychotic disorder
* Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)
* Non-English speaking
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03623620
Study Brief:
Protocol Section:
NCT03623620