Bipolar Disorder Clinical Trial
Official title:
Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers
Verified date | September 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Through a recent cross species translational experiment, researchers have identified a set of epigenetic marks capable of predicting postpartum depression with greater than 85% accuracy. The researchers are looking to identify a group of women from both the general population and those with a history of mood disorders who are at risk for postpartum depression and obtain brain imaging data at a postpartum time period prior to the onset of depressive symptoms and compare it with those obtained during depressive episodes. The researchers will also evaluate the efficacy of postpartum depression biomarker prediction.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 2020 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - pregnant women 18 or older with singleton pregnancy - with or without history of a mood disorder - may use psychiatric or Over-the-counter (OTC) medications - may have experienced preterm labor or delivery - must be willing to undergo repeated MRI scans (for wave 2) Exclusion Criteria: - current active suicidal ideation - medical or psychiatric instability - active substance abuse or dependence in last 90 days - any significant neurologic disease (wave 2) - presence of known infection, infarction, lesion in critical memory structures of brain (wave 2) - pace maker, aneurysm clips, artificial heart valve, ear implants, metal fragments (wave 2) - high risk pregnancy indications i.e. preeclampsia, genetic anomalies, women with HIV, Lupus, Irritable Bowel Syndrome (IBS) (wave 2) - implanted Intra-uterine devices (IUDs) or birth control prior to 6 weeks postpartum (wave 2) |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins East Baltimore Medical Campus | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Mental Health (NIMH) |
United States,
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* Note: There are 58 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epigenetic Analysis | One blood sample will be drawn in the third trimester and the epigenetic information obtained will be put into a model of prediction for postpartum depression. | At week 33 of pregnancy | |
Secondary | Brain Imaging | An functional MRI (fMRI) of hippocampal subregions and surrounding structures at a postpartum time period prior to the onset of depressive symptoms (2 weeks postpartum) and compared with those obtained during depressive episodes (6 weeks postpartum) to assess differences in functioning. | 4 Weeks |
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