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Trial record 65 of 256 for:    postpartum | "Depression"

Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers

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ClinicalTrials.gov Identifier: NCT03638687
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease
Post Partum Depression Bipolar Disorder

Detailed Description:
Postpartum depression (PPD) occurs in approximately 10-18% of women from the general population, affecting ~400,000 to 800,000 women each year. PPD results in significant morbidity to both mother and child, with offspring risks including low self-esteem, low intellectual skills, child abuse, and infanticide. PPD occurs within four weeks following parturition according to Diagnostic and Statistical Manual (DSM)-IV criteria and follows a dramatic drop in the circulating levels of estradiol (E2) and progesterone (P4). While PPD risk is not predicted by serum levels of gonadal hormones in humans, numerous studies suggest that risk to PPD is mediated by hormonal sensitivity. Recently, the investigators demonstrated that women at risk to PPD demonstrate an increased sensitivity to E2 mediated DNA methylation reprogramming at hippocampally relevant genes and identified two biomarkers, Tetratricopeptide repeat protein 9B (TTC9B) and heterochromatin protein 1 binding protein 3 (HP1BP3) that appeared functionally related to modulating neuroplasticity and which were predictive of PPD with 82-96% accuracy. Given that peripherally measurable epigenetic marks in genes implicated in hormone related neuroplastic changes may underlie risk to PPD, it is logical to next investigate neuroconnectivity alterations occurring longitudinally in the postpartum population at risk for PPD. The study is divided into two waves; in wave 1, the researchers will draw a tube of blood to be used as a biomarker screening to identify those at risk for PPD and matched controls, who will be asked to enter wave 2 of the study. In wave 2, women will undergo neuroimaging at weeks 2 and 6 postpartum in hopes to gather a neural signature of PPD prior to the onset of symptoms and while experiencing the symptoms. Additionally, data on a variety of candidate moderators of depression during or after pregnancy will be collected at each visit. This includes history of premenstrual symptoms, use of oral contraceptives, use of hormonal treatments to promote pregnancy and psychiatric history during previous pregnancies and the postpartum. Several measures of mood symptoms and anxiety symptoms will be administered including: Edinburgh Postnatal Depression Rating Scale (EPDS) which measures depressive symptoms in pregnant and postpartum mothers, the Young Mania Rating Scale, which rates manic and hypomanic symptoms, and the State Trait Anxiety Inventory, Perinatal Anxiety Scale, and the Penn State Worry questionnaire which measure anxiety symptoms. The Pittsburgh Sleep Quality Index scale will be administered at every visit to assess the role of sleep in the relapse of depression in the mothers. Two scales designed to measure stress will be administered to allow examination of its potential role in Major Depressive Disorder (MDD) relapse. The Recent Life Changes Scale, which measures stressful life events, will be administered at the Screening, 3rd trimester and 6 week visits. The Perceived Stress Scale which provides a subjective rating of the stress of will be administered at every visit. The investigators will also administer measures of childhood trauma, and note demographic information, medication usage, clinical history (e.g. number of hospitalizations, medication trials, etc.) and birth outcomes. These measures will be used in future exploratory analyses of potential moderators of epigenetic changes seen during and after pregnancy.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers
Actual Study Start Date : May 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
History, Yes PPD
Participants may be asked to undergo repeated neuroimaging scans. No intervention will be administered, all participants will receive routine care during the study.
No History, No PPD
Participants may be asked to undergo repeated neuroimaging scans. No intervention will be administered, all participants will receive routine care during the study.
History, No PPD
Participants may be asked to undergo repeated neuroimaging scans. No intervention will be administered, all participants will receive routine care during the study.
No History, Yes PPD
Participants may be asked to undergo repeated neuroimaging scans. No intervention will be administered, all participants will receive routine care during the study.



Primary Outcome Measures :
  1. Epigenetic Analysis [ Time Frame: At week 33 of pregnancy ]
    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.


Secondary Outcome Measures :
  1. Brain Imaging [ Time Frame: 4 Weeks ]
    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.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population includes women 18 years or older, pregnant with a singleton pregnancy, and with or without a history of a mood disorder. Participants may take psychiatric medications, however they may not be currently suicidal, psychiatrically unstable, or be currently abusing substances.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638687


Contacts
Contact: Zachary A Kaminsky, Ph.D. 613-722-6521 ext 7003 zkamins1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins East Baltimore Medical Campus Recruiting
Baltimore, Maryland, United States, 21205
Contact: Jennifer L Payne, MD    410-502-0050    jpayne5@jhmi.edu   
Principal Investigator: Zachary A Kaminsky, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Zachary A Kaminsky, Ph.D. Johns Hopkins University

Publications:
Guy, W., Clinical global impression. ECDEU Assessment Manual for Psychopharmacology, Revised. 1976, Rockville, MD: National Institute of Mental Health.

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03638687     History of Changes
Other Study ID Numbers: IRB00038271
R01MH104262 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Pregnancy
Postpartum

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Puerperal Disorders
Pregnancy Complications