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Duloxetine for Menopausal Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01117857
First received: May 3, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Depression
Menopause
Vasomotor Symptoms
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Duloxetine for Menopausal Depression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression [ Time Frame: Baseline to week 9 ] [ Designated as safety issue: No ]
    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:
  • Change in Menopause Symptoms as Measured by the Greene Climacteric Scale [ Time Frame: Baseline to week 9 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: Baseline to week 9 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI) [ Time Frame: Baseline to week 9 ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cymbalta

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117857

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Marlene P. Freeman, MD, Director of Clinical Services at the Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01117857     History of Changes
Other Study ID Numbers: 2009P000956
Study First Received: May 3, 2010
Results First Received: July 3, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014