NCT00296699已完成4 期
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D)
研究概览
简要总结
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
详细描述
This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DSM-IV Major Depression or Dysthymia with Atypical Features
- •Age 18-65
- •Physically healthy
- •HAMD(24) > 14
排除标准
- •Prior experience with Duloxetine
- •History of Psychosis or Bipolar Disorder, Borderline Personality Disorder
- •Unstable medical disorder; any history of Epilepsy
- •Currently taking medication that can interact with Duloxetine
- •Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- •Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization
- •Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine)
- •Pregnancy
- •Currently breast feeding
- •Fecund women failing to use acceptable birth control
- •Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode)
- •Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma)
- •Currently taking medication deemed effective
结局指标
主要结局
Hamilton Depression Scale (HAM-D)
时间窗: 10 weeks
次要结局
- Atypical Depression Diagnostic Scale (ADDS)(10 weeks)
- Beck Depression Inventory (BDI)(10 weeks)
- Clinical Global Impression (CGI)(10 weeks)
- Patient Global Impression (PGI)(10 weeks)
- Inventory of Depressive Symptoms(IDS)(10 weeks)
研究者
研究点 (1)
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