NCT00406848已完成4 期
Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression
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
- 370
- 试验地点
- 1
- 主要终点
- Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
- •Have a Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
- •Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator
排除标准
- •Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
- •Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
- •Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- •Have moderate to severe dementia
- •Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator
研究组 & 干预措施
Duloxetine
Experimental
干预措施: duloxetine hydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale
时间窗: baseline (Week 1), Week 13
The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
次要结局
- Change From Baseline on the 30-item Geriatric Depression Scale (GDS)(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores(baseline (Week 1), Week 13, Week 25)
- Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks(Week 13, Week 25)
- Change From Baseline in the Clinical Global Impression-Severity (CGI-S)(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in the Mini-Mental State Exam (MMSE)(baseline (Week 1), Week 9, Week 25)
- Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)(baseline (Week 1), Week 13, Week 25)
- Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10(Week 13, Week 25)
- Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score(Week 13, Week 25)
- Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)(Week 13, Week 25)
- Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3(Week 3)
- Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in Pulse Rate(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in Weight(baseline (Week 1), Week 13, Week 25)
- Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study(Baseline (Week 1) through Week 25)
- Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)(baseline (Week 1) through Week 25)
- Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation(baseline (Week 1) through Week 25)
- Change From Baseline in Laboratory Values - Platelet Count(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in Laboratory Values - Uric Acid(baseline (Week 1), Week 13, Week 25)
- Change From Baseline in Laboratory Values - Erythrocyte Count(baseline (Week 1), Week 25)
- Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)(baseline (Week 1), Week 25)
- Change From Baseline in Laboratory Values - Chloride and Fasting Glucose(baseline (Week 1), Week 25)
- Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count(baseline (Week 1) through Week 13)
- Change From Baseline in Electrocardiograms(baseline (Week 1), Week 25)
- Number of Participants With Successful Treatment Outcome(Baseline (Week 1) through Week 25)
- Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores(baseline (Week 1), Week 9, Week 25)
研究者
研究点 (1)
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