Duloxetine for Menopausal Depression

August 5, 2014 updated by: Marlene P. Freeman, MD, Massachusetts General Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression
Time Frame: 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.
Baseline to week 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Menopause Symptoms as Measured by the Greene Climacteric Scale
Time Frame: 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.
Baseline to week 9

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)
Time Frame: Baseline to week 9
The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.
Baseline to week 9
Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
Time Frame: Baseline to week 9
The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).
Baseline to week 9
Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)
Time Frame: Baseline to week 9
The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.
Baseline to week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P000956

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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