Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Depressive Symptom Scores at 8 Weeks
研究概览
简要总结
The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 20 and 65
- •Diagnosis of major depressive disorder (MDD) as assessed by the Structured Clinical Interview for DSM-IV (SCID-IV)
- •Individuals who provided written consent for participation.
排除标准
- •Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
- •Diagnosis of any Axis I disorder other than MDD or presence of symptoms requiring hospitalization
- •Intelligence quotient (IQ) below 80
- •Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
- •Unstable medical illness or other abnormalities observed at the screening or laboratory tests
- •Women who are pregnant, breastfeeding, or planning pregnancy
- •Allergy or tolerance to the clinical trial medication
- •Presence of any physical illness that contraindicates the clinical trial medication (e.g., epilepsy, history of uncontrollable narrow-angle glaucoma)
- •Use of psychoactive medications that may affect brain imaging findings
研究组 & 干预措施
Escitalopram + Bupropion
干预措施: Bupropion, Escitalopram (Drug)
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change from Baseline in Depressive Symptom Scores at 8 Weeks
时间窗: Baseline and at 8 Weeks
Change from Baseline in Depressive Symptom Scores at 4 Weeks
时间窗: Baseline and at 4 Weeks
Change from Baseline in Depressive Symptom Scores at 1 Week
时间窗: Baseline and at 1 Week
次要结局
- Number of Participants with Adverse Events(8 Weeks)
- Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks(Baseline and 8 Weeks)
- Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach(Baseline and 8 Weeks)
- Changes in Fatigue Severity Scale scores(Week 8)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University