NCT01724112已完成2 期
8-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of LY2940094 Administered Once Daily in Patients With Major Depressive Disorder (MDD)
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
- 136
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score
研究概览
简要总结
This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg) once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Have a diagnosis of MDD without psychotic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- •Have clinically significant depressive symptoms defined by a GRID Hamilton Depression Rating Scale 17 (HAMD17) Total Score ≥20 at screening
- •Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m²)
排除标准
- •Have a current or previous diagnosis of bipolar I or II disorder, MDD with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder
- •Currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode
- •Had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening
- •Have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety
研究组 & 干预措施
LY2940094
Experimental
40 mg administered orally as 1 capsule QD for 8 weeks.
干预措施: LY2940094 (Drug)
Placebo
Placebo Comparator
Administered orally as 1 capsule QD for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score
时间窗: Baseline, Week 8
次要结局
- Proportion of Participants Responding to Treatment(Baseline through Week 8)
- Proportion of Participants who Achieved Remission(Week 8)
- Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score(Baseline,Week 8)
- Clinical Global Impression - Improvement (CGI-I) Score at Week 8(Week 8)
- Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score(Baseline, Week 8)
- Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline, Week 4)
- Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score(Baseline, Week 8)
- Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC)(Baseline through 8 Weeks of Treatment)
研究者
研究点 (1)
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