Duloxetine for Menopausal Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression Menopause Vasomotor Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

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.

Interventions

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Duloxetine

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 Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No