Duloxetine for Menopausal Depression

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	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.

Primary Outcome Measures

Name	Time	Method
Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression	Baseline to week 9	The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.

Secondary Outcome Measures

Name	Time	Method
Change in Menopause Symptoms as Measured by the Greene Climacteric Scale	Baseline to week 9	The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.