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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676026
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE April 7, 2008
First Posted Date  ICMJE May 12, 2008
Results First Submitted Date  ICMJE March 20, 2017
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE May 2005
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
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. ]
Change History Complete list of historical versions of study NCT00676026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Official Title  ICMJE The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Zolpidem 1
    Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.
    Intervention: Drug: Zolpidem
  • Experimental: 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
  • Experimental: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2009)
8
Original Actual Enrollment  ICMJE
 (submitted: May 9, 2008)
5
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676026
Other Study ID Numbers  ICMJE 0505027759
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cynthia N Epperson, MD Yale School of Medicine
PRS Account University of Pennsylvania
Verification Date May 2017

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