跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT00536471
NCT00536471已完成4 期

Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 776 人开始时间: 2007年9月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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
776
试验地点
1
主要终点
Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)
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

Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.

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 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male or female outpatients
  • •Aged 18-65 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 Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2
  • •Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2
  • •Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and 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
  • •Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
  • •Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD
  • •Patients with uncontrolled narrow-angle glaucoma
  • •Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.

研究组 & 干预措施

A

Experimental

duloxetine 60 milligrams (mg) every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months

干预措施: Duloxetine hydrochloride (Drug)

B

Placebo Comparator

placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months

干预措施: Placebo (Drug)

结局指标

主要结局

Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)

时间窗: baseline, 8 weeks

Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).

次要结局

  • Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)(Baseline, 9 months)
  • Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores(Baseline, 12 weeks)
  • Abnormal Vital Signs at 9 Month Endpoint(9 months)
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)(Baseline, 8 weeks, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide(Baseline, 12 weeks, 9 Months)
  • Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities(Baseline, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in Weight(Baseline, 12 weeks, 9 months)
  • Abnormal Vital Signs at Anytime Over 12 Weeks(over 12 weeks)
  • Abnormal Vital Signs at 12 Week Endpoint(12 weeks)
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium(Baseline, 12 weeks, 9 months)
  • Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin(Baseline, 9 months)
  • Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint(9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness(Baseline, 12 weeks, 9 months)
  • Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect(Over 12 weeks)
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness(Baseline, 12 weeks, 9 months)
  • Probability of Response at 12 Week Endpoint(12 weeks)
  • Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)(Baseline, 12 weeks, 9 months)
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit(Baseline, 12 weeks, 9 months)
  • Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count(Baseline, 12 weeks, 9 months)
  • Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months(over 9 months)
  • Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).(Baseline, 12 weeks)
  • Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores(Baseline, 9 months)
  • Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7(Over 12 weeks)
  • Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect(over 12 weeks)
  • Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score(over 12 weeks)
  • Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint(12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)(Baseline, 12 weeks, 9 months)
  • Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate(Baseline, 12 weeks, 9 months)
  • Abnormal Vital Signs at Anytime Over 9 Months(over 9 months)
  • Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint(over 3 months)
  • Summary of Adverse Events Leading to Discontinuation(over 9 months)
  • Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase(baseline, 9 months)

研究者

申办方类型
Industry

研究点 (1)

Loading locations...

相似试验

已完成
3 期
Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia SyndromeFibromyalgia
NCT00190866Eli Lilly and Company210
已完成
3 期
A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety DisorderAnxiety Disorder
NCT00122837Eli Lilly and Company560
已完成
3 期
A Study in the Treatment of Children and Adolescents With Major Depressive DisorderMajor Depressive Disorder
NCT00849901Eli Lilly and Company337
已完成
3 期
A Study in the Treatment of Children and Adolescents With Major Depressive DisorderMajor Depressive Disorder
NCT00849693Eli Lilly and Company463
已完成
3 期
A Study for the Treatment of Diabetic Peripheral Neuropathic PainDiabetic Neuropathies
NCT00552175Eli Lilly and Company339
A Study Comparing Duloxetine and Placebo in... | 临床试验