Clinical trial NCT01117857: Duloxetine for Menopausal Depression
Official title: Duloxetine for Menopausal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Menopause
Vasomotor Symptoms
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 29
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression
timeFrame: Baseline to week 9
Secondary outcomes:
measure: Change in Menopause Symptoms as Measured by the Greene Climacteric Scale
timeFrame: Baseline to week 9
Other outcomes:
measure: Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Baseline to week 9
measure: Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: Baseline to week 9
measure: Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)
timeFrame: Baseline to week 9
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marlene P Freeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.