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

NCT00626340 | Completed Phase 4 Results

• 1 other identifier: 9907010780
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Depression

Keywords

menopause; women; major depressive disorder; Magnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

Study Arms (4)

MDD diagnosis and Estrogen treatment

ACTIVE COMPARATOR

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone.

Drug: MDD diagnosis and Estrogen treatment

MDD diagnosis and Fluoxetine treatment

ACTIVE COMPARATOR

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.

Drug: MDD diagnosis and Fluoxetine treatment

MDD diagnosis with both Estrogen and Fluoxetine treatment

ACTIVE COMPARATOR

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.

Drug: MDD diagnosis with both Estrogen and Fluoxetine treatment

No depression and estrogen treatment

ACTIVE COMPARATOR

Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.

Drug: No depression and estrogen treatment

Interventions

MDD diagnosis and Estrogen treatment DRUG

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.

MDD diagnosis and Estrogen treatment

MDD diagnosis and Fluoxetine treatment DRUG

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.

MDD diagnosis and Fluoxetine treatment

MDD diagnosis with both Estrogen and Fluoxetine treatment DRUG

Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.

MDD diagnosis with both Estrogen and Fluoxetine treatment

No depression and estrogen treatment DRUG

Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.

No depression and estrogen treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-70 years and able to give voluntary written informed consent.
• Meet DSM-IV criteria for major depression based on a structured clinical interview (SCID).
• Have no medical contraindication to estrogen. (This will include written documentation of a recent normal gynecological evaluation and mammogram).
• A minimum score of 25 on the 25-item Hamilton Depression Rating Scale on initial baseline rating which does not show improvement during the one-week observation period.
• Perimenopausal subjects will be those who have had irregular menses of either \<21 days or \>35 days for the previous six months to one year. Postmenopausal subjects will be those with no menstrual cycles and no hormone therapy for at least one year and serum FSH \>45.

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.
• 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.
• Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.).
• Evidence of substance use on urine toxicology screen done upon recruitment.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Cynthia Neill Epperson
• Organization: University of Pennsylvania

cepp@mail.med.upenn.edu

215-573-8871

Study Officials

• Cynthia N Epperson, MD

  University of Pennsylvania School of Medicine Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: July 1, 1999
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Locations

US (1)