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Duloxetine for Menopausal Depression - NCT01117857-02114(Clinical Trial 623580)



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City:  Boston
State:  
MA
Zip Code: 02114
Conditions: Depression - Menopause - Vasomotor Symptoms
Purpose: The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausal women. The secondary aim of the study is to examine if an eight-week intervention with duloxetine significantly reduces vasomotor symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in vasomotor symptoms in menopausal women.
Study summary:
Criteria: Inclusion Criteria: - Women age 40 years old or older - Menopausal symptoms of at least 3 months duration, including irregular periods and/or hot flushes - Minimum score of 15 on the Hamilton Rating Scale for Depression (17-item), - Patients will meet criteria for a major depressive episode, verified using the Mini International Neuropsychiatric Interview (MINI). - Subjects will be able to be treated on an outpatient basis, and - Subjects will be able to provide written informed consent Exclusion Criteria: - Subjects presently taking antidepressant medication, - Subjects currently using hormone replacement therapy, - Other Axis I disorders, except Generalized Anxiety Disorder or Panic Disorder, according to the Mini International Neuropsychiatric Interview (MINI) - "uncontrolled" narrow angle glaucoma - known hypersensitivity to duloxetine or any of the inactive ingredients - treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug. - Presence of psychotic symptoms, - History of mania or hypomania, - HAM-D suicide item score > 3, - End stage renal disease or severe renal impairment - Abnormal uterine bleeding (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods) that has not been evaluated by a gynecologist. - Subjects with serious or unstable medical illness, including alcohol or substance abuse, cardiovascular, hepatic, respiratory, endocrine, neuralgic, or hematologic disease, history of seizure disorder - Subjects taking medications that may interact with duloxetine
Study is available at: Massachusetts General Hospital
Boston, MA 02114
United States

Primary Contact:
Stephanie D Connors, BS
Email: sdconnors@partners.org
Phone: 617-724-6989
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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