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临床试验/NCT00105989
NCT00105989已完成3 期

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2005年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
514
试验地点
1
主要终点
Percentage of Participants With Depressive Recurrence After Time (t) in Days
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

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
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patient must be at least 18 years old.
  • •Patient must be diagnosed with depression and have had previous episodes of depression.
  • •Patient must sign informed consent.

排除标准

  • •Female and pregnant or breastfeeding.
  • •History of bipolar disorder, schizophrenia, or other psychotic disorders.
  • •Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
  • •Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
  • •Have taken an antidepressant called fluoxetine within 30 days of the start of the study.

研究组 & 干预措施

A

Experimental

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks

干预措施: Duloxetine (Drug)

B

Placebo Comparator

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks

干预措施: placebo (Drug)

结局指标

主要结局

Percentage of Participants With Depressive Recurrence After Time (t) in Days

时间窗: Every Visit from Week 34 up to Week 86 (Maintenance Phase)

Recurrence: Clinical Global Impression-Severity (CGI-S) score \>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.

次要结局

  • Recurrence Count(Every Visit from Week 35 up to Week 86 (Maintenance Phase))
  • Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days(Every Visit from Week 34 up to Week 86 (Maintenance Phase))
  • Loss of Response at Any Time(Every Visit from Week 35 up to Week 86 (Maintenance Phase))
  • Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases(Week 10 (Acute) and Week 34 (Continuation))
  • Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase(Week 86 (Maintenance Phase))
  • Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases(Week 0 through Week10 (Acute) through Week 34 (Continuation))
  • Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase(Week 34 through Week 86 (Maintenance Phase))
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase(Week 0 and Week 10)
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase(Week 0 and Week 10)
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase(Week 0 and Week 10)
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases(Week 0 and Week 10 (Acute) and Week 34 (Continuation))
  • Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase(Week 0 and Week 10)
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase(Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase(Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase))
  • Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase(Every Visit from Week 0 up to Week 10 (Acute))
  • Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase(Every Visit from Week 10 up to Week 34 (Continuation))

研究者

申办方类型
Industry

研究点 (1)

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