Dichotic Listening as a Predictor of Placebo and Medication Response in Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D)
研究概览
简要总结
Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific outcomes.
详细描述
100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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, 4th Edition 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, 17-item version > 20
- •Current (past six 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)
- •Bipolar I
- •Psychosis
- •If currently taking antidepressants or mood stabilizers, cannot be off psychotropic medication for 7 weeks (10 weeks for Prozac) or felt to require other psychiatric medication (other than occasional sleep or Anxiety medication)
- •Premenopausal women not using known effective birth control
- •Not currently depressed (whether considered due to current treatment or not)
- •Nonresponse to adequate trial of both study medications (i.e., > 4weeks on > escitalopram 30 mg/d, and imipramine 200 mg/d); patients having an inadequate response to one study medication could be enrolled and receive the other; patients having responded to an adequate trial of either study medication would be offered a retrial; also excluded will be subjects having non responded to an adequate trial with citalopram (i.e., > 4 weeks on > citalopram 60 mg/d)
- •Left-handed
研究组 & 干预措施
fluoxetine / Imipramine
fluoxetine or Imipramine
干预措施: Fluoxetine (Drug)
fluoxetine / Imipramine
fluoxetine or Imipramine
干预措施: Imipramine (Drug)
结局指标
主要结局
Hamilton Depression Scale (HAM-D)
时间窗: 6 weeks
The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of \<=7 are accepted as indicating "remission" and scores that have decreased \>= 50% from pre-treatment indicate positive "response". Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms.
次要结局
- Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)(6 weeks.)
研究者
Jonathan W Stewart, M.D
Clinical Psychiatrist
New York State Psychiatric Institute