CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
fluoxetinedrug
Likely dose
fluoxetine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00678574
NCT00678574Phase 4Completed
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The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder

University of Pennsylvania·interventional·Posted May 15, 2008·Updated Jul 27, 2018

In Brief

A Phase 4 clinical trial evaluating fluoxetine for Premenstrual Dysphoric Disorder and Premenstrual Syndrome. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremenstrual Dysphoric Disorder, Premenstrual Syndrome
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartMar 1, 1998
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 18.1 years ago

Interventions

fluoxetinedrug

Fluoxetine 20 mg daily by mouth for 2-3 months.