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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06382532
Enrollment
410
Registered
2024-04-24
Start date
2024-05-01
Completion date
2026-05-01
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Malingering

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.

Interventions

DIAGNOSTIC_TESTNiacin 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.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Niacin reaction testDuring the interventionTotal 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.

Secondary

MeasureTime frameDescription
Model specificity and sensitivityThrough study completion, an average of 2 yearsEvaluate the effectiveness of the classification model in identifying feigned depression patients through measures such as the area under curve (AUC), sensitivity (Sen), specificity (Sep), positive predictive value (PPV), and negative predictive value (NPV), where higher AUC, Sen, Sep, PPV, and NPV values indicate better classification performance of the model.
The F Scale in Minnesota Multiphasic Personality InventoryBaseline, pre-interventionThe F Scale in Minnesota Multiphasic Personality Inventory (MMPI) is used to detect attempts at fraud.

Countries

China

Contacts

Primary ContactJin Wang, Phd
sciaking@yeah.net15321000722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026