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Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

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ClinicalTrials.gov Identifier: NCT00676026
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Healthy
Interventions Drug: Fluoxetine
Drug: Zolpidem
Drug: Progesterone
Enrollment 8
Recruitment Details Participants were recruited at an outpatient research facility located at Yale University in New Haven, CT.
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
As far as we know, data was never analyzed for this study. We only know that 8 participants completed.
Age, Continuous   [1] 
Unit of measure:  Years
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: 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.
Sex: Female, Male   [1] 
Number Analyzed 0 participants
Female
Male
[1]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Each medication will be administered 2 times during a 1-month menstrual cycle.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Entire study duration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description 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.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Cynthia Neill Epperson, M.D.
Organization: University of Pennsylvania
Phone: 215-573-8871
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00676026     History of Changes
Other Study ID Numbers: 0505027759
First Submitted: April 7, 2008
First Posted: May 12, 2008
Results First Submitted: March 20, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017