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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00626340 |
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, allopregnanalone, pregnenolone, and pregnenolone sulfate.
Condition | Intervention | Phase |
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Menopause Depression |
Drug: estrogen alone Drug: fluoxetine alone Drug: estrogen and fluoxetine together |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Factorial Assignment |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | July 1999 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone.
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Drug: estrogen alone
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.
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2: Active Comparator
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
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Drug: fluoxetine alone
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.
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3: Active Comparator
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
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Drug: estrogen and fluoxetine together
Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.
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4: Active Comparator
Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.
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Drug: estrogen alone
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.
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Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria for Depressed Patients:
Exclusion criteria:
Inclusion Criteria for Healthy Subjects:
Exclusion Criteria for Healthy Subjects:
United States, Connecticut | |
Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health | |
New Haven, Connecticut, United States, 06511 |
Principal Investigator: | Cynthia N Epperson, MD | Yale School of Medicine |
Responsible Party: | Yale University School of Medicine Department of Psychiatry ( C. Neill Epperson ) |
Study ID Numbers: | 9907010780 |
Study First Received: | February 21, 2008 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00626340 |
Health Authority: | United States: Institutional Review Board |
menopause women major depressive disorder Magnetic Resonance Spectroscopy |
Fluoxetine Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Depressive Disorder Serotonin Menopause Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |