Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT)

NCT06382532 | Not Yet Recruiting

• 1 other identifier: AFMMUChina_NSRT
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Malingering

Outcome Measures

Primary Outcomes (1)

• Niacin reaction test

  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.

  During the intervention

Secondary Outcomes (2)

• Model specificity and sensitivity

  Through study completion, an average of 2 years

• The F Scale in Minnesota Multiphasic Personality Inventory

  Baseline, pre-intervention

Study Arms (3)

Healthy control group

1. M.I.N.I scale rating without any mental disorder; 2. Patient Health Questionnaire (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.

Diagnostic Test: Niacin skin reaction test

Depressive disorder group

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

Diagnostic Test: Niacin skin reaction test

Depressive disorder malinger group

1. Clinical complaints meeting Diagnostic and Statistical Manual of Mental Disorders (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.

Diagnostic Test: Niacin skin reaction test

Interventions

Niacin skin reaction test DIAGNOSTIC_TEST

Nicotinic skin reaction, also known as nicotinic flush reaction, occurs when a solution of nicotinic acid methyl ester briefly contacts the skin. Following penetration through the skin barrier into the subcutaneous tissue, it generates nicotinic acid (vitamin B3). Under the action of phospholipase A2 (PLA2), cyclooxygenase (COX), and other enzymes, arachidonic acid (AA) on the cell membrane is cleaved to produce prostaglandins, leading to local vasodilation, increased blood perfusion, and the transient appearance of erythema on the skin.

Depressive disorder group; Depressive disorder malinger group; Healthy control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Depressive Disorder Malinger Group 2. Depressive Disorder Group 3. Healthy Control Group

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Medical Center

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (5)

• 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.

  PMID: 33677199 BACKGROUND

• 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.

  PMID: 9516668 BACKGROUND

• 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.

  PMID: 29077970 BACKGROUND

• 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.

  PMID: 20417059 BACKGROUND

• 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.

  PMID: 36521667 RESULT

MeSH Terms

Conditions

Depressive Disorder; Malingering

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jin Wang, Phd

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Wang, Phd

CONTACT

15321000722; sciaking@yeah.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CN (1)