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

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00676026

Purpose

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.

Condition	Intervention
Healthy	Drug: Fluoxetine Drug: Zolpidem Drug: Progesterone

MedlinePlus related topics: Menstruation

Drug Information available for: Fluoxetine Progesterone Fluoxetine hydrochloride Zolpidem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Single Blind (Subject), Active Control, Single Group Assignment
Official Title:	The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

Further study details as provided by Yale University:

Primary Outcome Measures:

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. [ Time Frame: Each medication will be administered 2 times during a 1-month menstrual cycle. ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Zolpidem 1: No Intervention Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.	Drug: Zolpidem Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
Progesterone 2: No Intervention Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.	Drug: Progesterone Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.
Fluoxetine 3: No Intervention Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.	Drug: Fluoxetine Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676026

Locations

United States, Connecticut
Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Cynthia N Epperson, MD

Yale School of Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Yale University School of Medicine Department of Psychiatry ( C. Neill Epperson, M.D. )
Study ID Numbers:	0505027759
Study First Received:	April 7, 2008
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00676026
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

menses
women
healthy controls
Healthy females with regular menstrual cycles

Study placed in the following topic categories:

Fluoxetine
Zolpidem
Progesterone
Healthy
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Psychotropic Drugs
Central Nervous System Depressants
Hormones
Serotonin Uptake Inhibitors
Pharmacologic Actions

Serotonin Agents
GABA Agonists
Therapeutic Uses
Progestins
Hypnotics and Sedatives
GABA Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009