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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). 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.
Primary Outcome
GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.
Interventions
- DRUG fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 1998-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00678574 record still lists
NCT00678574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which fluoxetine is the first listed.
NCT00678574 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00678574's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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