Duloxetine for Perimenopausal Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00517985

Run by

University of Arizona

People needed

7

Starts

2007-02-01

Expected to finish

2008-06-01

Last updated by the study team

2012-07-09

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Women's Mental Health Program; University of Arizona; Department of Psychiatry — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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