Phase 4
N=22
Duloxetine for Menopausal Depression
Depression · Menopause · Vasomotor Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01117857 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression — -7.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression |
-7.5 | — |
| SECONDARY Change in Menopause Symptoms as Measured by the Greene Climacteric Scale |
-7.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01117857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.