Clinical trial NCT00676026: Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Official title: The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: menses
women
healthy controls
Healthy females with regular menstrual cycles
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 (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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Each medication will be administered 2 times during a 1-month menstrual cycle.
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Cynthia N Epperson, MD
role: PRINCIPAL_INVESTIGATOR
References: