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

Not yet recruiting

• Conditions: Depressive Disorder; Malingering
• Interventions: Diagnostic Test: Niacin skin reaction test

• Registration Number: NCT06382532
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Study Start: 2024-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 410

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depressive disorder group	Niacin skin reaction test	1. Patients with a first depressive disorder meeting DSM-5 criteria; 2. Age 18-60 years, Males; 3. Voluntary informed consent.
Depressive disorder malinger group	Niacin skin reaction test	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.
Healthy control group	Niacin skin reaction test	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.

Primary Outcome Measures

Name	Time	Method
Niacin reaction test	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.

Secondary Outcome Measures

Name	Time	Method
The F Scale in Minnesota Multiphasic Personality Inventory	Baseline, pre-intervention	The F Scale in Minnesota Multiphasic Personality Inventory (MMPI) is used to detect attempts at fraud.
Model specificity and sensitivity	Through study completion, an average of 2 years	Evaluate 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.

Trial Locations

Locations (1)

Air Force Medical Center; 🇨🇳 Beijing, Beijing, China