Status:
COMPLETED
Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Lead Sponsor:
University of Pennsylvania
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 (p...
Eligibility Criteria
Inclusion
- Women ages 18-45 and able to give voluntary written informed consent;
- Regular menstrual periods of 24-35 days in length;
- Body mass index 18.5 to 30 kg/m2;
- No past or present DSM-IV psychiatric or substance dependence diagnosis by structured diagnostic interview (SCID-NP); no substance abuse history within the previous 2 years;
- Absence of mood symptoms across the menstrual cycle during one month of prospective daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has been used in numerous studies to confirm the presence or absence of significant premenstrual mood and behavioral difficulties;
- Must be willing and able to participate in at least three of the four challenge paradigms.
Exclusion
- Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);
- Family history of first degree relative with an Axis I psychiatric or substance dependence disorder (excepting alcohol and nicotine) (per subject report);
- Current treatment with psychoactive medication;
- Diabetes controlled by means other than diet;
- Use of steroid contraceptives (any method involving hormones) within the previous 4 months;
- Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on any particular occasion; must be willing to abstain from alcohol consumption for 48 hours prior to each 1H-MRS scan;
- Implanted metallic devices.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00676026
Start Date
May 1 2005
End Date
February 1 2009
Last Update
June 1 2017
Active Locations (1)
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1
Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health
New Haven, Connecticut, United States, 06511