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The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder

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ClinicalTrials.gov Identifier: NCT00678574
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : July 17, 2017
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.

Condition or disease Intervention/treatment Phase
Premenstrual Dysphoric Disorder Premenstrual Syndrome Drug: fluoxetine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
Study Start Date : March 1998
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Premenstrual Dysphoric Disorder (PMDD) group
PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months
 Drug: fluoxetine
Fluoxetine 20 mg daily by mouth for 2-3 months.
Other Names:
  • Prozac
  • Sarafem
No Intervention: Healthy controls


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment [ Time Frame: 2-3 months post-treatment w/ fluoxetine. ]
    GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 - 45 years old and able to give voluntary written informed consent.
  • Willing to complete a daily log of mood symptoms for 7 consecutive menstrual cycles: two menstrual cycles during the Screening Phase (Phase 1), one menstrual cycle during the Testing Phase (Phase 2), and four menstrual cycles during the Medication Treatment Phase and Post-Treatment Phase (Phase 3). All subjects who successfully complete Phases 1 and 2, and the Medication Treatment Phase, will be invited to participate in Phase 3 approximately three months later. Phase 3 will involve repeating all procedures conducted in Phase 2, including the daily log of mood symptoms.
  • Meet DSM-IV criteria for premenstrual dysphoric disorder, confirmed by the Daily Record of Severity of Problems (DRSP; Endicott & Harrison) for 2 consecutive menstrual cycles (Phase 1). The DRSP is a self-rated symptom checklist, which requires individuals to rate their symptoms of PMDD according to the DSM-IV research criteria scale on a scale from 1 (symptom not present) to 6 (symptom extreme). During the last 7 days of the menstrual cycle compared to days 5-11, patients must have a 30% increase in their average (over 2 menstrual cycles) score for 5 of these 10 symptoms. Symptoms must be "not present" or "minimal" during the postmenstrual week.
  • Average 19-item Hamilton Depression Rating Scale (HAM-D) scores < 5 during the follicular phase and > 16 during the luteal phase.
  • Have regular menstrual cycles 28 to 32 days in length. Each of the screening cycles must be ovulatory as confirmed by plasma progesterone levels of >5 ng/ml during the luteal phase.

Exclusion Criteria:

  • Presence of any other comorbid DSM-IV Axis I disorder.
  • Meeting DSM-IV criteria for psychoactive substance (excluding nicotine) dependence within the preceding 4 months.
  • A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
  • Use of anticonvulsant or benzodiazepines within the last month.
  • Use of psychotropic medication in last week (except as stated above).
  • Use of steroid contraceptives within the previous 4 months, including birth control pill, birth control patch, birth control ring, and Depo-Provera®. Subjects will be asked to use abstinence or the barrier method (condoms) as forms of contraception in this study.
  • Alcohol consumption greater than 7 drinks/week.
  • Current pregnancy.
  • Metallic implants.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678574


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Cynthia N Epperson, MD University of Pennsylvania School of Medicine Department of Psychiatry
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00678574    
Other Study ID Numbers: 9803010098
First Posted: May 15, 2008    Key Record Dates
Results First Posted: July 17, 2017
Last Update Posted: July 27, 2018
Last Verified: July 2017
Keywords provided by University of Pennsylvania:
hormones
menses
PMS
PMDD
Additional relevant MeSH terms:
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Premenstrual Syndrome
Premenstrual Dysphoric Disorder
Pathologic Processes
Menstruation Disturbances
Depressive Disorder
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors