NCT00795821已完成2 期
A Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment With LY2216684 in Adult Patients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10
研究概览
简要总结
The purpose of this study is to assess whether LY2216684 is superior to placebo in the treatment of adult patients with 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-65 years
- •Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (DSM-IV-TR) criteria without psychotic features
- •Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
- •Grid 17-item Hamilton Rating Scale for Depression (GRID-HAMD17) total score ≥18 at Visit 1 and Visit 2
- •Clinical global impressions of severity (CGI-S) score ≥4 at Visit 1 and Visit 2
排除标准
- •Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
- •Have previously completed or withdrawn from this study or any other study investigating LY2216684
- •Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
- •Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of Visit 1
- •Have an Axis II disorder that would interfere with protocol compliance
- •Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia, or other psychotic disorder
- •Have a history of substance abuse within the past 1 year
- •Women who are pregnant or breast-feeding
- •Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgment of the investigator, considered to have treatment-resistant depression
- •Participants who are judged to be at serious suicidal risk
- •Have a serious or unstable medical illness
- •Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
- •Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1
- •Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
- •Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year
- •Have a history of any seizure disorder (other than febrile seizures)
- •Require psychotropic medication other than sedative/hypnotic medication for sleep
- •Have a thyroid stimulating hormone (TSH) level outside the established reference range.
- •Are taking or have received treatment with any excluded medication within 7 days prior to Visit 2
- •Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
- •A positive urine drug screen for any substance of abuse at Visit 1
- •Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment
研究组 & 干预措施
LY2216684
Experimental
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
干预措施: LY2216684 (Drug)
Placebo
Placebo Comparator
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10
时间窗: Baseline, Week 10
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
次要结局
- Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10(Baseline, Week 10)
- Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10(Baseline, Week 10)
- Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10(Baseline, Week 10)
- Percentage of Participants Reporting Resource Utilization at Week 62(Baseline (Week 10) through Week 62)
- Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10(Baseline through Week 10)
- Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62(Baseline (Week 10) through Week 62)
- Mean Change From Baseline (Week 10) in Supine Pulse at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10(Baseline, Week 10)
- Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62(Baseline (Week 10), Week 62)
- Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10(Baseline, Week 10)
- Percentage of Participants Reporting Resource Utilization at Week 10(Baseline through Week 10)
- Mean Change From Baseline in Supine Pulse at Week 10(Baseline, Week 10)
- Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684(Baseline through Week 62)
- Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62(Baseline (Week 10), Week 62)
研究者
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