Duloxetine for Menopausal Depression

Massachusetts General Hospital29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression Menopause Vasomotor Symptoms

Interventions

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression

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.

Time frame: Baseline to week 9

Secondary Outcomes

Change in Menopause Symptoms as Measured by the Greene Climacteric Scale

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.