Duloxetine for Menopausal Depression

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Duloxetine Hydrochloride

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