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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00678574 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Premenstrual Dysphoric Disorder Premenstrual Syndrome |
Drug: fluoxetine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder |
| Enrollment: | 20 |
| Study Start Date: | March 1998 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06511 | |
| Principal Investigator: | Cynthia N Epperson, MD | Yale University School of Medicine Department of Psychiatry |
More Information
| Responsible Party: | Yale University School of Medicine Department of Psychiatry ( C. Neill Epperson, M.D. ) |
| Study ID Numbers: | 9803010098 |
| Study First Received: | May 13, 2008 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00678574 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
hormones menses PMS PMDD |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Fluoxetine Serotonin Agents |
Pathologic Processes Menstruation Disturbances Mental Disorders Therapeutic Uses Syndrome Mood Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents Premenstrual Syndrome |