Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Yale University National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00678574 |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | March 1998 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn Czarkowski, MA | 203-764-9934 | kathryn.czarkowski@yale.edu |
United States, Connecticut | |
Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health | Recruiting |
New Haven, Connecticut, United States, 06511 | |
Principal Investigator: Cynthia N Epperson, MD |
Principal Investigator: | Cynthia N Epperson, MD | Yale University School of Medicine Department of Psychiatry |
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: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00678574 |
Health Authority: | United States: Institutional Review Board |
hormones menses PMS PMDD |
Fluoxetine Depression Menstruation Disturbances Mental Disorders |
Mood Disorders Depressive Disorder Serotonin Premenstrual Syndrome |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Pathologic Processes Serotonin Agents Therapeutic Uses Syndrome Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |