Duloxetine for Menopausal Depression

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Menopause; Vasomotor Symptoms; Depression

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT01117857

2009P000956

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Duloxetine

Experimental group

Description:

After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.

Treatment:

Drug: Duloxetine