Duloxetine for Menopausal Depression
Primary Purpose
Depression, Menopause, Vasomotor Symptoms
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Duloxetine
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01117857
First Posted
May 3, 2010
Last Updated
August 5, 2014
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01117857
Brief Title
Duloxetine for Menopausal Depression
Official Title
Duloxetine for Menopausal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Menopause, Vasomotor Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
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.
Primary Outcome Measure Information:
Title
Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression
Description
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 Outcome Measure Information:
Title
Change in Menopause Symptoms as Measured by the Greene Climacteric Scale
Description
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.
Time Frame
Baseline to week 9
Other Pre-specified Outcome Measures:
Title
Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
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.
Time Frame
Baseline to week 9
Title
Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
Description
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).
Time Frame
Baseline to week 9
Title
Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)
Description
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.
Time Frame
Baseline to week 9
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene P Freeman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23602542
Citation
Freeman MP, Hirschberg AM, Wang B, Petrillo LF, Connors S, Regan S, Joffe H, Cohen LS. Duloxetine for major depressive disorder and daytime and nighttime hot flashes associated with the menopausal transition. Maturitas. 2013 Jun;75(2):170-4. doi: 10.1016/j.maturitas.2013.03.007. Epub 2013 Apr 17.
Results Reference
result
Links:
URL
http://www.womensmentalhealth.org/clinical-and-research-programs/registry-signup/
Description
Related Info
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Duloxetine for Menopausal Depression
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