Duloxetine for Perimenopausal Depression

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

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).