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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH134904 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Premenstrual dysphoric disorder (PMDD) is a severe affective disorder impacting millions of women worldwide, thought to be due to altered sensitivity to hormone fluctuations across the menstrual cycle. Neuroactive steroid hormones (NAS) and the gamma-aminobutyric acid (GABA)-A receptor (GABAAR) are thought to play a role in PMDD. This research will assess the blood levels of GABAergic NAS, expression of associated enzymes, and expression of GABAAR subunits across the premenstrual (luteal) phase of the menstrual cycle in healthy controls and individuals with PMDD. Within the PMDD group, the investigators will assess how these measures are affected by a low-dose antidepressant medication versus placebo. The results will provide a comprehensive view of the changes in these systems across the menstrual cycle and will add to the investigator's understanding of the mechanisms that underlie PMDD, as well as therapeutic mechanisms of PMDD treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants delegated to the "control" arm will be individuals without premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across the menstrual cycle, answer self-report surveys, and complete four blood draws. | |
| PMDD with sertraline | Active Comparator | Participants delegated to the "PMDD with sertraline" arm will be individuals with severe premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across two menstrual cycles, answer self-report surveys, and complete eight blood draws (four in each menstrual cycle). In the second cycle, participants in this arm will take a daily pill of 50 mg of sertraline from ovulation until menses onset (end of menstrual cycle 2). |
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| PMDD with placebo | Placebo Comparator | Participants delegated to the "PMDD with placebo" arm will be individuals with severe premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across two menstrual cycles, answer self-report surveys, and complete eight blood draws (four in each menstrual cycle). In the second cycle, participants in this arm will take a daily placebo pill from ovulation until menses onset (end of menstrual cycle 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline 50 mg daily | Drug | The intervention will be in the form of an oral pill, taken daily, from the day of positive urine ovulation test result until the day of menses onset. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroactive Steroid Levels | The primary outcome variable is levels of neuroactive steroids in blood; from the early luteal phase (2 days post ovulation) compared to the late luteal phase (days 5 to 1 prior to predicted menses onset) | Post ovulation up to 2 days, up to 5 days pre-menses prediction |
| Measure | Description | Time Frame |
|---|---|---|
| Neurosteroidogenic enzyme expression levels | Neurosteroidogenic enzyme expression levels will be measured in the early luteal phase (2 days post ovulation) and the late luteal phase (days 5 to 1 prior to predicted menses onset). Levels will be compared between the healthy controls and PMDD groups at cycle 1, and between sertraline and placebo groups at cycle 2, respectively; between cycle 1 (first menstrual cycle when blood draws will be completed) and until the end of the participants' time on the study (2-3 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Paone, B.S. | Contact | 4436854258 | vpaone1@jh.edu | |
| Victoria Seo, B.S. | Contact | vseo1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Liisa Hantsoo, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Mental Health Center | Recruiting | Baltimore | Maryland | 21205 | United States |
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| Placebo Oral Tablet | Drug | The placebo oral tablet will be of the same shape, color, and manufacturer as the sertraline 50 mg oral tablets. Tablet will be taken daily, from the day of positive urine ovulation test result until the day of menses onset. |
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| First menstrual cycle, up to 3 months |
| GABAAR subunit expression levels | GABAAR subunit expression will be measured in the early luteal phase (2 days post ovulation) and the late luteal phase (days 5 to 1 prior to predicted menses onset). The investigators will compare GABAAR subunit expression levels between controls and PMDD groups at L1, and between sertraline and placebo groups at L2, respectively; between cycle 1 (first menstrual cycle when blood draws will be completed) and until the end of the participants' time on the study (2-3 months) | first menstrual cycle, up to 3 months |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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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 |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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