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

NCT00676026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-06-01

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Fluoxetine

Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.

DRUG

Zolpidem

Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.

DRUG

Progesterone

Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.

Sponsors & Collaborators

Principal Investigators

  • Cynthia N Epperson, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676026 on ClinicalTrials.gov