ChiCTR2000032447Not yet recruitingEarly Phase 1
肺结核后抑郁的临床队列及血清生物标志物研究
上海肺科医院临床研究基金1 site in 1 country792 target enrollmentStarted: July 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 792
- Locations
- 1
- Primary Endpoint
- 代谢组学
Study Overview
Brief Summary
探讨膳食炎症指数纵向轨迹与肺结核人群并发抑郁风险的关联；分析肺结核后抑郁病人和肺结核病人之间血清代谢物水平差异，从中找到新型生物标志物。
Study Design
- Study Type
- 观察性研究
- Primary Purpose
- 析因分组（即根据危险因素或暴露因素分组）
- Masking
- N/a
Eligibility Criteria
- Ages
- 18 to 65 (—)
- Sex
- Male
Inclusion Criteria
- •意识清楚，思维正常，能进行语言沟通；
- •符合中华医学会呼吸病分会 2013 年修订的肺结核诊断标准的病人；
- •符合美国精神病学会《精神障碍诊断和统计手册》DSM-V 抑郁诊断规范；
- •PHQ-9 抑郁量表≥10 分；
- •取得知情同意、自愿参与本干预计划的病人；
- •年龄大于等于 18 周岁、小于等于 65 周岁。
Exclusion Criteria
- •有精神疾病病史及意识障碍、慢性呼吸衰竭、肺性脑病等严重并发症的病人；
- •甲状腺疾病等与代谢相关疾病者；
- •需要持续无创或有创通气者，血流动力学不稳定者；
- •合并心、肾功能不全病人；
- •肢体活动障碍病人；不能配合测量病人；禁食超过 1 天的病人。
Arms & Interventions
肺结核并发抑郁症组
肺结核组
Outcomes
Primary Outcomes
代谢组学
Secondary Outcomes
- 抑郁量表
- 营养状况
Investigators
Study Sites (1)
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