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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

April 7, 2008
August 24, 2009
May 2005
February 2009   (final data collection date for primary outcome 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. [ Time Frame: Each medication will be administered 2 times during a 1-month menstrual cycle. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00676026 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Healthy
  • Drug: Fluoxetine
    Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
    Other Name: Prozac
  • Drug: Zolpidem
    Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
    Other Name: Ambien
  • 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: Zolpidem 1
    Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.
    Intervention: Drug: Zolpidem
  • No Intervention: Progesterone 2
    Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.
    Intervention: Drug: Progesterone
  • No Intervention: Fluoxetine 3
    Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.
    Intervention: Drug: Fluoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00676026
0505027759
No
C. Neill Epperson, M.D., Yale University School of Medicine Department of Psychiatry
Yale University
Not Provided
Principal Investigator: Cynthia N Epperson, MD Yale School of Medicine
Yale University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP