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The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women with premenstrual dysphoric disorder (PMDD) is of interest, this study is designed primarily for those women without a psychiatric illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolpidem 1 | Experimental | Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle. |
|
| Progesterone 2 | Experimental | Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle. |
|
| Fluoxetine 3 | Experimental | Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls. | This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. | Each medication will be administered 2 times during a 1-month menstrual cycle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia N Epperson, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health | New Haven | Connecticut | 06511 | United States |
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Participants were recruited at an outpatient research facility located at Yale University in New Haven, CT.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As far as we know, data was never analyzed for this study. We only know that 8 participants completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable. |
| 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 | To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls. | This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. | UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable. | Posted | Each medication will be administered 2 times during a 1-month menstrual cycle. |
|
Entire study duration.
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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 | All Participants | This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. |
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| 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 |
|---|---|
| D005473 | Fluoxetine |
| D000077334 | Zolpidem |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 |
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| Zolpidem | Drug | Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant. |
|
|
| Progesterone | Drug | Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle. |
|
|
| years |
| Sex: Female, Male | UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable. |
|
| OG000 | All Participants | This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information. |
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |