Major Depressive Disorder Clinical Trial
Official title:
Duloxetine for Perimenopausal Depression
Verified date | July 2012 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Recently, antidepressants have been explored as a class of medications to treat major depression in the context of perimenopause, as well as the somatic symptoms of perimenopause (such as hot flashes). Duloxetine (Cymbalta) is one of the newer antidepressants approved for the treatment of Major Depressive Disorder (MDD). Therefore, the current study is designed to assess the efficacy of duloxetine in a sample of women who are perimenopausal and meet criteria for MDD. We will assess impact on MDD and perimenopausal symptoms.
Status | Completed |
Enrollment | 7 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Women age 40 years old or older. - Perimenopausal symptoms of at least 3 months duration, including irregular periods and/or hot flashes. - Minimum score of 15 on the Hamilton Rating Scale for Depression (17-item). - Subjects must be able to be treated on an outpatient basis. - Subjects must be able to provide written informed consent. Exclusion Criteria: - Subjects presently taking antidepressant medication. - Subjects currently using hormone replacement therapy. - Subjects who are pregnant. - Subjects who have hepatic disease. - Other Axis I disorders, except Generalized Anxiety Disorder or Panic Disorder. - "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 study drug administration 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. - Hamilton Rating Scale for Depression (HAM-D) suicide item score > 2. - End stage renal disease or severe renal impairment. - Abnormal uterine bleeding that has not been evaluated by a gynecologist (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods). |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Women's Mental Health Program; University of Arizona; Department of Psychiatry | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | Eli Lilly and Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the initial HAM-D by 50% or more at week 9 of the trial | 9 Weeks | No | |
Primary | Reduction of the HAM-D score to less than or equal to 7 at week 9 | 9 Weeks | No | |
Primary | Change of CGI score achievement to "very much improved" or "much improved" at week 9 | 9 Weeks | No | |
Primary | A 50% decrease in the GCS at week 9. | 9 Weeks | No |
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