Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression (HAMD)
研究概览
简要总结
Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Patients in different groups will be treated by psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12 weeks of treatment.
详细描述
Patients meeting the inclusion criteria undergo an examination that included a diagnostic interview, vision test, and psychophysiological measures. Participants then undergo the baseline fMRI scan within 48 hours, after that, they will receive psychotherapy or SSRI treatment.and returned the scan once they completed the therapy.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meet SCID -Ⅰ/P major depressive disorder diagnosis;
- •Right handedness;
- •good visual acuity.
排除标准
- •neurological disease ;
- •serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
- •with other mental disorder;
- •psychotic symptoms
- •personality disorders;
- •pregnancy;
- •suicidal risk;
- •treatment by antidepressants or other psychotropic medications within 6 months prior to the start of the trial;
- •with contraindication for MRI
研究组 & 干预措施
Cognitive-Behavior Therapy group
treatment with Cognitive-Behavior Therapy
干预措施: Cognitive-Behavior Therapy (Behavioral)
SSRI antidepressants
treatment by SSRI antidepressant
干预措施: SSRI antidepressants (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAMD)
时间窗: an expected average of 6 months
The 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms. Minimum and maximum possible values are respectively 0 and 78. Lower scores show more mild depression.
次要结局
- Magnetic Resonance Imaging(an expected average of 6 months)
研究者
Chun Wang
The attending physician, Dr.
Nanjing Medical University