NCT04430556Unknown不适用
Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients
Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response on Hamilton Anxiety Rating Scale
研究概览
简要总结
The objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •First-time patients, without prior antidepressant treatment that meet the diagnostic criteria of DSM 5 for major depressive disorder.
- •Patients who meet the current major depressive disorder criteria in the MINI interview.
- •Patients who signed the informed consent for the investigation.
排除标准
- •Patients presenting insufficient data in the MINI interview for current major depression.
- •Patients diagnosed with intellectual development disorder, by clinic.
- •Patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by clinic and / or by the MINI interview.
- •Patients with contraindications for MRI.
- •Patients with serious or unstable medical problems.
- •Patients undergoing some legal procedure.
- •Patients with difficulties in understanding the interview or completing the assessment instruments.
研究组 & 干预措施
Volumetric changes in response to sertraline or escitalopram
Other
干预措施: Sertraline (Drug)
结局指标
主要结局
Response on Hamilton Anxiety Rating Scale
时间窗: Change from baseline to week 8
The Hamilton Anxiety Rating Scale and its correlation with hippocampal size
次要结局
- Response on Montgomery-Asberg Scale for Depression(Change from baseline to week 8)
- Response on Hamilton Depression Rating Scale(Change from baseline to week 8)
- Response on Clinical Global Impression-Improvement(Change from baseline to week 8)
- Response on Columbia Scale for Suicidality(Change from baseline to week 8)
- Response on State-Trait Depression Inventory(Change from baseline to week 8)
- Response on Beck Anxiety Inventory(Change from baseline to week 8)
- Response on EQ-5D(Change from baseline to week 8)
研究者
José Alfonso Ontiveros Sánchez De la Barquera
Associate Professor
Hospital Universitario Dr. Jose E. Gonzalez
研究点 (1)
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