Duloxetine for Menopausal Depression
Condition: Depression; Menopause; Vasomotor Symptoms
MeSH terms: Depression; Depressive Disorder
Intervention: Duloxetine
Intervention description: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility 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