Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
研究概览
简要总结
The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 18 years or older who meet criteria for Major Depressive Disorder (MDD).
- •Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressant for at least a month for the treatment of depression.
- •Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.
排除标准
- •Women who are pregnant or plan to be pregnant or are breastfeeding.
- •To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication.
- •Diagnosed with treatment resistant depression.
- •History of bipolar disorder, schizophrenia, or other psychotic disorders.
- •To have previously taken duloxetine that didn't work.
- •Judged to be at serious suicidal risk in the opinion of the investigator and/or score >=3 on Item 3 (suicide) of the 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (Visit 2).
- •A serious medical illness that may need treatment during the study.
- •Taking certain medications that are not allowed in this study.
- •To have a history of alcohol and/or drug abuse or dependence within the past year.
- •To have uncontrolled narrow-angle glaucoma.
- •To have allergic reactions to many medicines.
- •To have undergone "shock" therapy (Electroconvulsive Therapy) or "magnet" treatment (Transcranial Magnetic Stimulation) within the past year.
- •To initiate "talk therapy" (psychotherapy) just before or during the study.
- •To have chronic pain and you have been taking medicine for it for the last 6 months.
- •To have certain liver diseases.
- •To have kidney disease or undergoing dialysis.
- •Abnormal thyroid stimulating hormone (TSH) concentration.
研究组 & 干预措施
Duloxetine
Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
时间窗: Baseline, 4 weeks
BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a \>=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
次要结局
- Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks(Baseline, 4 weeks, 8 weeks)
- Change From Baseline HAMD-17 Total Score at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline HAMD-17 Core Subscale at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline HAMD-17 Maier Subscale at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks(Baseline, 8 weeks)
- Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks(8 weeks)
- Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks(Baseline, 4 Weeks, 8 weeks)
- Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks(Baseline, 4 weeks, 8 weeks)
- Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks(Baseline, 4 weeks, 8 weeks)