Clinical trial NCT06382532: Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT)
Official title: Biological Diagnostic Techniques for the Diagnosis of Depressive Disorders Malinger Based on the Niacin Skin Response Test (NSRT)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Depressive Disorder
Malingering
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 410
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Depressive Disorder Malinger Group
2. Depressive Disorder Group
3. Healthy Control Group

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Depressive Disorder Malinger Group:

1. Clinical complaints meeting DSM-5 criteria for the diagnosis of depressive disorder;
2. Patients with first-episode fraudulent disease who meet the DSM-5 criteria for the diagnosis of Z76.5;
3. Age 18-60 years, Males;
4. Voluntary informed consent.

Depressive Disorder Group:

1. Patients with a first depressive disorder meeting DSM-5 criteria;
2. Age 18-60 years, Males;
3. Voluntary informed consent.

Healthy control group:

1. M.I.N.I scale rating without any mental disorder;
2. PHQ-9 \<5 ;
3. No history of mental illness, no family genetic history;
4. Age 18-60 years old, Males;
5. Voluntary informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: Niacin reaction test
timeFrame: During the intervention
Secondary outcomes:
measure: Model specificity and sensitivity
timeFrame: Through study completion, an average of 2 years
measure: The F Scale in Minnesota Multiphasic Personality Inventory
timeFrame: Baseline, pre-intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Air Force Medical Center
state: Beijing
Study officials:
affiliation: Air Force Military Medical University, China
name: Jin Wang, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang DD, Hu XW, Jiang J, Sun LY, Qing Y, Yang XH, Gao Y, Cui GP, Li MH, Wang PK, Zhang J, Zhuang Y, Li ZZ, Li J, Guan LL, Zhang TH, Wang JJ, Ji F, Wan CL. Attenuated and delayed niacin skin flushing in schizophrenia and affective disorders: A potential clinical auxiliary diagnostic marker. Schizophr Res. 2021 Apr;230:53-60. doi: 10.1016/j.schres.2021.02.009. Epub 2021 Mar 4.
citation: Ward PE, Sutherland J, Glen EM, Glen AI. Niacin skin flush in schizophrenia: a preliminary report. Schizophr Res. 1998 Feb 9;29(3):269-74. doi: 10.1016/s0920-9964(97)00100-x.
citation: Sun L, Yang X, Jiang J, Hu X, Qing Y, Wang D, Yang T, Yang C, Zhang J, Yang P, Wang P, Cai C, Wang J, He L, Wan C. Identification of the Niacin-Blunted Subgroup of Schizophrenia Patients from Mood Disorders and Healthy Individuals in Chinese Population. Schizophr Bull. 2018 Jun 6;44(4):896-907. doi: 10.1093/schbul/sbx150.
citation: Messamore E, Hoffman WF, Yao JK. Niacin sensitivity and the arachidonic acid pathway in schizophrenia. Schizophr Res. 2010 Sep;122(1-3):248-56. doi: 10.1016/j.schres.2010.03.025. Epub 2010 Apr 24.
citation: Wang J, Qing Y, Liang J, Cui G, Wang Q, Zhang J, Yang X, Li M, Wang D, Fan Z, Chu K, Zhang J, Ke X, Wan C. Identification of adolescent patients with depression via assessment of the niacin skin flushing response. J Affect Disord. 2023 Mar 1;324:69-76. doi: 10.1016/j.jad.2022.12.017. Epub 2022 Dec 12.