Duloxetine for Menopausal Depression
This study has been completed.
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
First received: May 3, 2010
Last updated: June 18, 2014
Last verified: June 2014
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Duloxetine for Menopausal Depression
Primary Outcome Measures:
- Change in depression scores as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline, week 1, week 2, week 3, week 5, week 7, and week 9 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in menopause symptoms as measured by the Greene Climacteric Scale [ Time Frame: Measure assessed at baseline, week 1, week 2, week 3, week 5, week 7, and week 9 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
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.
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
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
||Marlene P Freeman, MD
||Massachusetts General Hospital
No publications provided
||Marlene P. Freeman, MD, Director of Clinical Services at the Center for Women's Mental Health, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 3, 2010
||June 18, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Dopamine Uptake Inhibitors
Central Nervous System Agents