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临床试验/NCT06382532
NCT06382532尚未招募不适用

Biological Diagnostic Techniques for the Diagnosis of Depressive Disorders Malinger Based on the Niacin Skin Response Test (NSRT)

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
410
试验地点
1
主要终点
Niacin reaction test

研究概览

简要总结

This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test.

详细描述

Depressive disorder malingers are prevalent, and it is difficult to recognize. As an objective and scientific endophenotype of depressive disorders, the blunted features in NSRT are determined by genetic factors and are not influenced by the mental state of individual subjects at a particular moment, which can provide a reliable retrospective biological index for the determination of mental and psychological state of depressive disorder malinger.

This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger, explore the application prospects of this technology in the field of biological identification, and establish a high-specificity biological diagnostic model for depressive disorder malinger and validate and optimize it, so as to provide a biological basis for the accurate and efficient identification of depressive disorder malingers using objective indexes in the process of clinical practice.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Depressive Disorder Malinger Group:
  • Clinical complaints meeting DSM-5 criteria for the diagnosis of depressive disorder;
  • Patients with first-episode fraudulent disease who meet the DSM-5 criteria for the diagnosis of Z76.5;
  • Age 18-60 years, Males;
  • Voluntary informed consent.
  • Depressive Disorder Group:
  • Patients with a first depressive disorder meeting DSM-5 criteria;
  • Age 18-60 years, Males;
  • Voluntary informed consent.
  • Healthy control group:
  • M.I.N.I scale rating without any mental disorder;
  • PHQ-9 <5 ;
  • No history of mental illness, no family genetic history;
  • Age 18-60 years old, Males;
  • Voluntary informed consent form.

排除标准

  • History of traumatic brain injury;
  • Continuous use of non-steroidal anti-inflammatory drugs within the last two weeks.

结局指标

主要结局

Niacin reaction test

时间窗: During the intervention

Total niacin reaction score: It includes one value (Total Area), which refers to the sum of nicotinic acid reaction areas for each concentration (a total of 360) collected within 10 minutes from 60 images. Total single point score for niacin reaction: It includes six values, each representing the sum of nicotinic acid reaction areas for individual concentrations (a total of 360) collected within 10 minutes from 60 images. Niacin reaction speed: It includes one value (EC50), representing the time required for the nicotinic acid reaction of the first concentration to reach half of the plateau phase. Niacin flush color: It includes one value (Total Color), which refers to the color value of 6 flush areas in the images captured at the 10th minute.

次要结局

  • The F Scale in Minnesota Multiphasic Personality Inventory(Baseline, pre-intervention)
  • Model specificity and sensitivity(Through study completion, an average of 2 years)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Wang

Principal Investigator

Air Force Military Medical University, China

研究点 (1)

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