Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder

Phase 4

Completed

• Conditions: Menopause; Depression
• Interventions: Drug: MDD diagnosis and Estrogen treatment; Drug: MDD diagnosis and Fluoxetine treatment; Drug: MDD diagnosis with both Estrogen and Fluoxetine treatment; Drug: No depression and estrogen treatment

• Registration Number: NCT00626340
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2017-03-17
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-25
• Last Update Submitted: 2017-05-25
• Results First Posted: 2017-06-01
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MDD diagnosis and Estrogen treatment	MDD diagnosis and Estrogen treatment	Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone.
MDD diagnosis and Fluoxetine treatment	MDD diagnosis and Fluoxetine treatment	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 treatment	MDD diagnosis with both Estrogen and Fluoxetine treatment	Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
No depression and estrogen treatment	No depression and estrogen treatment	Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.

Primary Outcome Measures

Name	Time	Method
Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.	Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone	This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.; We only know that 18 participants completed, but as far as we know data was never analyzed for these 18 participants.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States