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

NCT00676026 | Completed Results

• 1 other identifier: 0505027759
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

menses; women; healthy controls; Healthy females with regular menstrual cycles

Outcome Measures

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.

  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.

  Each medication will be administered 2 times during a 1-month menstrual cycle.

Study Arms (3)

Zolpidem 1

EXPERIMENTAL

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

Drug: Zolpidem

Progesterone 2

EXPERIMENTAL

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

Drug: Progesterone

Fluoxetine 3

EXPERIMENTAL

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

Drug: Fluoxetine

Interventions

Fluoxetine DRUG

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

Also known as: Prozac

Fluoxetine 3

Zolpidem DRUG

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

Also known as: Ambien

Zolpidem 1

Progesterone DRUG

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

Also known as: Prometrium

Progesterone 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

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

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Fluoxetine; Zolpidem; Progesterone

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Cynthia Neill Epperson, M.D.
• Organization: University of Pennsylvania

cepp@mail.med.upenn.edu

215-573-8871

Study Officials

• Cynthia N Epperson, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: May 12, 2008
• Study Start: May 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Locations

US (1)