Duloxetine for Menopausal Depression
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01117857
First received: May 3, 2010
Last updated: May 14, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2012 |
| 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
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:
No publications provided
| 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 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013