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

NCT ID: NCT06382532

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 410 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-01

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.

Conditions

Depressive Disorder; Malingering

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Niacin skin reaction test

Intervention Type: 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

1. Patients with a first depressive disorder meeting DSM-5 criteria;

2. Age 18-60 years, Males;

3. Voluntary informed consent.

Niacin skin reaction test

Intervention Type: 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 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.

Niacin skin reaction test

Intervention Type: 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.

Interventions

Niacin skin reaction 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Jin Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Wang, Phd

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

Air Force Medical Center

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jin Wang, Phd

Role: CONTACT

sciaking@yeah.net

15321000722

Facility Contacts

Jin Wang

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 33677199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9516668 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29077970 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20417059 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36521667 (View on PubMed)

Other Identifiers

AFMMUChina_NSRT

Identifier Type: -

Identifier Source: org_study_id