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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premenstrual Dysphoric Disorder (PMDD) group | Experimental | PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months |
|
| Healthy controls | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluoxetine | Drug | Fluoxetine 20 mg daily by mouth for 2-3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment | GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI. | 2-3 months post-treatment w/ fluoxetine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia N Epperson, MD | University of Pennsylvania School of Medicine Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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45 subjects were recruited at an outpatient practice at Yale University, CT.
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| ID | Title | Description |
|---|---|---|
| FG000 | PMDD | Participants who qualified as having PMDD received fluoxetine 20 mg daily by mouth for 2-3 months |
| FG001 | Healthy Controls | Participants who did not qualify for a diagnosis of PMDD and did not receive drug treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PMDD Group | Fluoxetine 20 mg daily by mouth for 2-3 months to the PMDD group |
| BG001 | Healthy Controls | No intervention was provided to the healthy control group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment | GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI. | This study was conducted at Yale several years ago. Our group at UPenn only has basic information about this study. This includes the number of participants, which was 18, and that no adverse events occurred. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania. | Posted | 2-3 months post-treatment w/ fluoxetine. |
|
Adverse event data was collected throughout the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluoxetine | Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group | 0 |
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Data from this study has not yet been analyzed nor peer reviewed. As much information as possible was entered into the results section of this trial, however information is missing as it pertains to specific measurements collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Neill Epperson, M.D. | University of Pennsylvania | 215-573-8871 | cepp@mail.med.upenn.edu |
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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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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
No intervention was provided in the healthy control group. |
|
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | No Treatment | Healthy controls received no treatment. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |