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NCT00678574 · ClinicalTrials.gov registry record · Phase 4
The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT00678574: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00678574 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00678574, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study 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.
Interventions
- DRUG fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 1998-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678574
The ClinicalTrials.gov registry entry for NCT00678574 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which fluoxetine is the first listed.
NCT00678574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00678574 about?
NCT00678574 is a clinical study titled "The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder". 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 fo...
What is the current status of trial NCT00678574?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 1998-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00678574?
The interventions under investigation include: fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00678574?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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