NCT01070329已完成4 期
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 527
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
研究概览
简要总结
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
- •Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
- •At least 1 previous episode of depression
- •Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
- •A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
- •Written informed consent
排除标准
- •Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
- •Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
- •Women of child-bearing potential who are not using a medically accepted means of contraception
- •Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- •Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
- •Have any prior history of bipolar disorder, psychosis, or schizophrenia
- •Have an Axis II disorder that would interfere with study compliance
- •Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment resistant depression
- •Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
- •Diagnosis of acute liver injury or severe cirrhosis
- •Uncontrolled narrow-angle glaucoma
- •Positive urine drug screen for any substance of abuse
- •Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
- •History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
- •Requires continuous use of analgesics for 6 or more months because of chronic pain
- •Has pain of a known origin
- •Meets criteria for fibromyalgia as defined by the American College of Rheumatology
- •Experiences greater than or equal to 1 migraine headache per week
- •Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
- •Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
- •Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
- •Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
- •Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days after discontinuation of study drug
- •Abnormal thyroid stimulating hormone
- •Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures
研究组 & 干预措施
Duloxetine
Experimental
干预措施: Duloxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
时间窗: Day 1 through 8 weeks
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
时间窗: Baseline, 8 weeks
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.
次要结局
- Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8(Baseline, 8 weeks)
- Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8(Baseline, up to 8 weeks)
- Percentage of Participants Achieving Remission up to Week 8(Up to 8 weeks)
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4(Baseline, 4 weeks)
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2(Baseline, 2 weeks)
- Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8(Baseline, 8 weeks)
- Patient Global Impression of Improvement (PGI-I) Score at Week 8(8 weeks)
- Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase(Baseline through 8 weeks)
研究者
研究点 (1)
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