Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 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
This research aims to investigate the efficacy and safety of buspirone in treating generalized anxiety disorder with depressive symptoms and to evaluate its neuroprotective effects using magnetic resonance imaging.
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 (Outcomes Assessor)
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
- 是
入选标准
- •Men and women aged between 20 and 65
- •Diagnosis of generalized anxiety disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV)
- •Depressive symptom scores measured by Hamilton Depression Rating Scale at screening and baseline assessments: >=8 and <=16
- •Healthy Control Subject Inclusion Criteria
- •Healthy men and women aged between 20 and 65
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.)
- •Drug abuse in past 3 months
- •Contraindications to magnetic resonance imaging (e.g., pacemaker implantation，claustrophobia, etc.)
- •Diagnosis of any Axis I disorder other than generalized anxiety disorder or presence of symptoms requiring hospitalization
- •Major depressive episode during past 12 months
- •Depressive symptom scores measured by Hamilton Depression Rating Scale: >=17
- •Women who are pregnant, breastfeeding, or planning pregnancy
- •Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)
- •Unstable medical illness or severe abnormality in laboratory test at screening assessment
- •Use of psychoactive medications that may affect brain imaging findings
- •Intelligence quotient below 80
研究组 & 干预措施
buspirone+alprazolam
干预措施: buspirone+alprazolam (Drug)
alprazolam
干预措施: alprazolam (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 anxiety symptom scores at 4 weeks
时间窗: baseline and at 4 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
change from baseline in anxiety symptom scores at 8 weeks
时间窗: baseline and at 8 weeks
change from baseline in anxiety symptom scores at 1 week
时间窗: baseline and at 1 week
次要结局
- changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach(baseline and at 8 weeks)
- number of participants with adverse events(1 week)
研究者
In Kyoon Lyoo, MD, PhD, MMS
Professor
Seoul National University Hospital