Duloxetine for Menopausal Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression, Menopause, Vasomotor Symptoms

In brief

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.

Key facts

Study ID

NCT01117857

Run by

Massachusetts General Hospital

People needed

29

Starts

2009-08-01

Expected to finish

2011-06-01

Last updated by the study team

2014-08-21

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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