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

NCT ID: NCT00676026

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-02-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Zolpidem 1

Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

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

Progesterone 2

Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

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

Fluoxetine 3

Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

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

Interventions

Fluoxetine

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

Intervention Type: DRUG

Zolpidem

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

Intervention Type: DRUG

Progesterone

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

Intervention Type: DRUG

Other Intervention Names

Prozac; Ambien; Prometrium

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia N Epperson, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0505027759

Identifier Type: -

Identifier Source: org_study_id