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NCT00626340 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Depression and Menopause, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 4
Development phase
18
Enrollment target
1
Study location

NCT00626340 is a Phase 4 study of Depression and Menopause that has completed, run by University of Pennsylvania. The registered enrollment target is 18 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00626340, a Phase 4 study of Depression and Menopause, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 4
Development phase
18 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

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

Study Locations (1)

Connecticut

  • Yale University - New Haven

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 1999-07
Est. Completion 2008-07
Phase Phase 4

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT00626340

The ClinicalTrials.gov registry entry for NCT00626340 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions - of which MDD diagnosis and Estrogen treatment is the first listed.

NCT00626340 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT00626340 about?

NCT00626340 is a clinical study titled "Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder". 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 estr...

What is the current status of trial NCT00626340?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 1999-07. Estimated completion is 2008-07.

What conditions does trial NCT00626340 study?

This clinical trial studies the following conditions: Depression, Menopause.

What interventions are being tested in trial NCT00626340?

The interventions under investigation include: 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 (DRUG).

Who is sponsoring clinical trial NCT00626340?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00626340 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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