- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638687
Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers
September 18, 2020 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins East Baltimore Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At week 33 of pregnancy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zachary A Kaminsky, Ph.D., Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Tanaka M, Sokabe M. Bidirectional modulatory effect of 17beta-estradiol on NMDA receptors via ERalpha and ERbeta in the dentate gyrus of juvenile male rats. Neuropharmacology. 2013 Dec;75:262-73. doi: 10.1016/j.neuropharm.2013.07.029. Epub 2013 Aug 14.
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- Fester L, Labitzke J, Hinz R, Behem C, Horling K, Bernhard T, Bader MI, Vollmer G, Rune GM. Estradiol responsiveness of synaptopodin in hippocampal neurons is mediated by estrogen receptor beta. J Steroid Biochem Mol Biol. 2013 Nov;138:455-61. doi: 10.1016/j.jsbmb.2013.09.004. Epub 2013 Sep 25.
- Suda S, Segi-Nishida E, Newton SS, Duman RS. A postpartum model in rat: behavioral and gene expression changes induced by ovarian steroid deprivation. Biol Psychiatry. 2008 Aug 15;64(4):311-9. doi: 10.1016/j.biopsych.2008.03.029. Epub 2008 May 8.
- Green AD, Galea LA. Adult hippocampal cell proliferation is suppressed with estrogen withdrawal after a hormone-simulated pregnancy. Horm Behav. 2008 Jun;54(1):203-11. doi: 10.1016/j.yhbeh.2008.02.023. Epub 2008 Mar 12.
- Bennett MR. The prefrontal-limbic network in depression: Modulation by hypothalamus, basal ganglia and midbrain. Prog Neurobiol. 2011 Apr;93(4):468-87. doi: 10.1016/j.pneurobio.2011.01.006. Epub 2011 Feb 22.
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- Silverman ME, Loudon H, Safier M, Protopopescu X, Leiter G, Liu X, Goldstein M. Neural dysfunction in postpartum depression: an fMRI pilot study. CNS Spectr. 2007 Nov;12(11):853-62. doi: 10.1017/s1092852900015595.
- Leibenluft E, Yonkers KA. The ties that bind: maternal-infant interactions and the neural circuitry of postpartum depression. Am J Psychiatry. 2010 Nov;167(11):1294-6. doi: 10.1176/appi.ajp.2010.10081159. No abstract available.
- Barrett J, Wonch KE, Gonzalez A, Ali N, Steiner M, Hall GB, Fleming AS. Maternal affect and quality of parenting experiences are related to amygdala response to infant faces. Soc Neurosci. 2012;7(3):252-68. doi: 10.1080/17470919.2011.609907. Epub 2011 Sep 26.
- Laurent HK, Ablow JC. A face a mother could love: depression-related maternal neural responses to infant emotion faces. Soc Neurosci. 2013;8(3):228-39. doi: 10.1080/17470919.2012.762039. Epub 2013 Jan 21.
- Deligiannidis KM, Sikoglu EM, Shaffer SA, Frederick B, Svenson AE, Kopoyan A, Kosma CA, Rothschild AJ, Moore CM. GABAergic neuroactive steroids and resting-state functional connectivity in postpartum depression: a preliminary study. J Psychiatr Res. 2013 Jun;47(6):816-28. doi: 10.1016/j.jpsychires.2013.02.010. Epub 2013 Mar 15.
- Bannbers E, Gingnell M, Engman J, Morell A, Sylven S, Skalkidou A, Kask K, Backstrom T, Wikstrom J, Poromaa IS. Prefrontal activity during response inhibition decreases over time in the postpartum period. Behav Brain Res. 2013 Mar 15;241:132-8. doi: 10.1016/j.bbr.2012.12.003. Epub 2012 Dec 10.
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
August 16, 2018
First Submitted That Met QC Criteria
August 16, 2018
First Posted (Actual)
August 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00038271
- R01MH104262 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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