CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
MDD diagnosis and Estrogen treatment +3 moredrug
Likely dose
Not stated in 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/NCT00626340
NCT00626340Phase 4Completed
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Measurement of GABA and Neurosteroid Levels in Women With Menopausal Major Depression Before and After Treatment With Estrogen Alone, Fluoxetine Alone, or Estrogen and Fluoxetine and Normal Controls Before and After Treatment With Estrogen

University of Pennsylvania·interventional·Posted Feb 29, 2008·Updated Jun 1, 2017

In Brief

A Phase 4 clinical trial evaluating MDD diagnosis and Estrogen treatment, MDD diagnosis and Fluoxetine treatment, and 2 other interventions for Menopause and Depression. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects before and after estrogen replacement, and after fourteen days of medroxyprogesterone administration; and 2) in depressed menopausal subjects before and after treatment of their depression with antidepressant alone, estrogen alone or antidepressant plus estrogen. Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels. Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and pregnenolone sulfate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Depression
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 29, 2008
Enrollment StartJul 1, 1999
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 18.3 years ago

Interventions

MDD diagnosis and Estrogen treatmentdrug

Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause.

MDD diagnosis and Fluoxetine treatmentdrug

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.

MDD diagnosis with both Estrogen and Fluoxetine treatmentdrug

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.

No depression and estrogen treatmentdrug

Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.