Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Information source: Yale University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Fluoxetine (Drug); Zolpidem (Drug); Progesterone (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Cynthia N Epperson, MD, Principal Investigator, Affiliation: Yale School of Medicine
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 (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.
Clinical Details
Official title: The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Study design: Other, Non-Randomized, Single Blind (Subject), Active Control, Single Group Assignment
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health, New Haven, Connecticut 06511, United States
Additional Information
Starting date: May 2005
Ending date: May 2010
Last updated: May 9, 2008
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