Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D)
研究概览
简要总结
The main purpose of this study is to correlate brain testing with treatment outcome.
详细描述
40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Age 18-65
- •Physically healthy
- •Normal hearing
- •Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)
排除标准
- •Hearing deficit in one or both ears
- •Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
- •History of Psychosis or Epilepsy
- •Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- •Unstable medical problem
- •Insufficient English for neuropsychological and dichotic testing
- •Bipolar I
- •Need for wash-out from effective treatment in order to participate
- •High suicide risk
- •Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
研究组 & 干预措施
escitalopram
escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d
干预措施: Escitalopram (Drug)
bupropion
bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d
干预措施: Bupropion (Drug)
imipramine
imipramine 50 mg/d for 3 days, then 100 mg/d for 4 days, then 150 mg/d for 3 days then 200 mg/d for 4 days then 250 mg/d for a week and then 300 mg/d thereafter, 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: 7 mos.
次要结局
- Beck Depression Inventory (BDI)(7 mos.)
- Clinical Global Impression (CGI)(7 mos.)
- Patient Global Impression (PGI)(7 mos.)
- Inventory of Depressive Symptoms (IDS)(7 mos.)
- Edinburgh Handedness Inventory(7 mos.)
- Chapman Pleasure Scale(7 mos.)
- Spielberger State/Trait Anxiety Inventory(7 mos.)