Dichotic Listening as a Predictor of Medication Response in Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D)
研究概览
简要总结
This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.
详细描述
Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning , and do not show an advantage of drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. Preferential hemisphere for auditory processing will be correlated with treatment outcome.
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
- •Ages between 18-65
- •Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified
排除标准
- •Known Hearing impairment
- •Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis).
- •Hamilton Rating Scale for Depression (HAMD), 21-item total score >20
- •Current (past 6 months)alcohol and/or drug abuse or dependence
- •Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine)
- •Non-response to adequate trial of study medication (i.e., > or = 4 weeks on > or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d)
- •Premenopausal women not using known effective birth control
- •Not currently depressed (whether considered due to current treatment or not)
- •History of seizure, seizure disorder, anorexia nervosa, or bulimia
- •Left-handed -
研究组 & 干预措施
escitalopram
escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d
干预措施: escitalopram (Drug)
bupropion
bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
干预措施: bupropion (Drug)
imipramine
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
干预措施: imipramine (Drug)
结局指标
主要结局
Hamilton Depression Scale (HAM-D)
时间窗: 6 weeks or last visit in Phase
Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.
次要结局
- Clinical Global Impression Scale (CGI)(6 weeks or last visit in Phase)