Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT01117857
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT01117857
Study Brief:
Protocol Section:
NCT01117857