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

Completed · Phase 4

Conditions studied: Menopause, Depression

In brief

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.

Key facts

Study ID

NCT00626340

Run by

University of Pennsylvania

People needed

18

Starts

1999-07-01

Expected to finish

2008-07-01

Last updated by the study team

2017-06-01

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Meeting DSM-IV for any other Axis I disorder.
• A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
• A history of moderate to severe endometriosis; milder cases will require subject's Gynecologists permission to participate.
• Use of anticonvulsants or benzodiazepines within the last month.
• Use of psychotropic medication in last week (except as stated above).
• Use of alcohol within last month.
• Current pregnancy (for the perimenopausal subjects).
• Positive urine drug screen.
• Metallic implants.
• Inclusion Criteria for Healthy Subjects:
• No DSM-IV psychiatric or substance abuse diagnosis by structured diagnostic interview (SCID).
• No medical contraindication to estrogen (this will include written documentation of a recent normal gynecological exam with mammogram).
• Matched to depressed patients by age and menopausal status.
• Have no menstrual cycles or hormone therapy for at least one year or irregular menses of either <21 days or 35 days for the previous six months to one year.
• Exclusion Criteria for Healthy Subjects:
• Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.).
• Evidence of substance use on urine toxicology screen done upon recruitment.
• Current treatment with psychoactive medication.
• Diabetes controlled by means other than diet.
• Use of alcohol within last month.
• Implanted metallic devices.
• Positive urine drug screen.

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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