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

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00676026

Run by

University of Pennsylvania

People needed

8

Starts

2005-05-01

Expected to finish

2009-02-01

Last updated by the study team

2017-06-01

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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