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Completed

NCT Number: NCT00676026

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoxetine

Drug

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

Other names: Prozac

zolpidem

Drug

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

Other names: Ambien

Progesterone

Drug

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

Other names: Prometrium

Primary outcomes

  1. 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.

    This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 12, 2008
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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