Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Quality of Life Scale (QOLS)
研究概览
简要总结
The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.
The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.
详细描述
Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.
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
- 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
- •Age : 18-65
- •Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks
- •MADRS total score of 18 or higher
- •Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration
- •Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)
排除标准
- •Past history of hypersensitivity to aripiprazole
- •Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia
- •Clinically significant current Axis II (DSM-IV-TR) diagnosis
- •A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator
- •Pregnancy or in breast-feeding
- •Presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function
- •Patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics
- •Patients with past treatment failures of aripiprazole
研究组 & 干预措施
Aripiprazole 8-week group
Adjunctive aripiprazole 8-week treatment
干预措施: Aripiprazole 6-week group (Drug)
Aripiprazole 6-week group
Adjunctive aripiprazole 6-week treatment
干预措施: Aripiprazole 8-week group (Drug)
结局指标
主要结局
Quality of Life Scale (QOLS)
时间窗: Change from Baseline at 8 weeks
change of Quality of Life Scale (QOLS)
次要结局
- Montgomery-Åsberg Depression Rating Scale(Change from Baseline at 8 weeks)
研究者
Yong Min Ahn
Professor
Seoul National University Hospital