Duloxetine for Menopausal Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression
时间窗: Baseline to week 9
The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.
次要结局
- Change in Menopause Symptoms as Measured by the Greene Climacteric Scale(Baseline to week 9)
研究者
Marlene P. Freeman, MD
Director of Clinical Services at the Center for Women's Mental Health
Massachusetts General Hospital