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

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00676026
First received: April 7, 2008
Last updated: August 24, 2009
Last verified: August 2009
  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

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

Resource links provided by NLM:


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: 8
Study Start Date: May 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Zolpidem 1
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.
Other Name: Ambien
No Intervention: Progesterone 2
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.
Other Name: Prometrium
No Intervention: Fluoxetine 3
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.
Other Name: Prozac

  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

No publications provided

Responsible Party: C. Neill Epperson, M.D., Yale University School of Medicine Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00676026     History of Changes
Other Study ID Numbers: 0505027759
Study First Received: April 7, 2008
Last Updated: August 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
menses
women
healthy controls
Healthy females with regular menstrual cycles

Additional relevant MeSH terms:
Fluoxetine
Zolpidem
Progesterone
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypnotics and Sedatives
Central Nervous System Depressants
GABA-A Receptor Agonists
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on April 15, 2014