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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH135896 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this study aim to determine if these biomarkers also distinguish PMDD cases from healthy controls at different points in the menstrual cycle. By collecting biological samples (such as blood) and monitoring mood changes across the menstrual cycle, the investigators will be able to determine whether these epigenetic markers are associated with PMDD. The investigators plan to study these epigenetic markers during the follicular phase (roughly the first half of the menstrual cycle, from menses until ovulation) and the luteal phase (roughly the second half of the menstrual cycle, from ovulation to menses). The investigators will study this in two groups: 1) individuals who do NOT have premenstrual mood symptoms, and 2) individuals with premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD). The results will provide a comprehensive view of the changes in these systems across the menstrual cycle. This will add to the investigators understanding of the mechanisms that may cause PMS/PMDD.
Premenstrual dysphoric disorder (PMDD) is a reproductive affective disorder with impairing mood symptoms that emerge monthly in the premenstrual (luteal) phase of the menstrual cycle. Reproductive affective disorders, including PMDD and postpartum depression, can be conceptualized as disorders of hormone sensitivity - an abnormal brain response to ovarian hormone fluctuations. Epigenetic variations in prior studies by the investigators were prospectively predictive of postpartum depression risk with over 80% accuracy. Recently, in a cross-sectional cohort of 50 women with and without PMDD, this postpartum depression epigenetic biomarker distinguished PMDD cases from controls in the luteal phase, suggesting this may indicate sensitivity to reproductive hormone change. The primary aim of this study is to explore whether this epigenetic biomarker is a broad marker for hormone sensitivity, by assessing women (controls, PMDD) in both the follicular and luteal phases of the participant's menstrual cycles, using a repeated measures approach. A secondary aim is to examine whether the epigenetic biomarkers differ between women with PMDD who have responded to selective serotonin reuptake inhibitor (SSRI) treatment versus those who have failed SSRIs. SSRIs are the first-line treatment for PMDD, yet many PMDD patients do not respond to SSRIs. This study will assess DNA methylation in a cohort of women with PMDD and controls. The investigators will compare the epigenetic biomarker between controls and PMDD in the follicular and luteal phases. Within the PMDD group, the investigators will compare the biomarker between those who have responded to SSRI treatment and those who have not. Blood will be collected at home by participants using a dried blood spot collection system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms. | ||
| Premenstrual Dysphoric Disorder (PMDD) | Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of DNA Methylation Biomarkers (Comparing individuals with PMDD and controls) | In the luteal phase, DNA methylation variations at HP1BP3, TTC9B will distinguish controls from individuals with PMDD. In the follicular phase, DNA methylation variations at HP1BP3 and TTC9B will not distinguish controls from PMDD. The investigators will be collecting dried blood spots and assaying these epigenetic markers using various DNA methylation techniques. | From enrollment until study completion (approximately 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of DNA Methylation Biomarkers (comparing history of SSRI treatment vs SSRI non response) | In the luteal phase, DNA methylation variations at HP1BP3, TTC9B will distinguish those with a history of SSRI treatment response versus SSRI non-response among women with PMDD. In the follicular phase, DNA methylation variations at HP1BP3, TTC9B will not distinguish those with a history of SSRI treatment response versus SSRI non-response among women with PMDD. Samples from which these assays are performed are from dried blood spots. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from Virginia, Washington DC, and Maryland (Baltimore area).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Seo, B.S. | Contact | 302-464-8320 | vseo1@jh.edu | |
| Victoria Paone, B.S. | Contact | vpaone1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Liisa Hantsoo, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Reproductive Mental Health Center | Recruiting | Baltimore | Maryland | 21205 | United States |
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| Label | URL |
|---|---|
| The study information and a link to the screening form will be on this page following IRB approval. | View source |
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
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| From enrollment until study completion (approximately 3 months) |
| Epigenetic biomarkers associated with PMDD | Novel epigenetic biomarkers associated with PMDD will be identified using dried blood spots and associated methods and techniques for analysis. | From enrollment until study completion (approximately 3 months) |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |