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Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder
NCT00626340 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 1999-07 |
| Est. Completion | 2008-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00626340
The ClinicalTrials.gov registry entry for NCT00626340 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00626340 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00626340?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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