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

April 23, 2024 updated by: Jin Wang, Air Force Military Medical University, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Air Force Medical Center
        • Contact:
          • Jin Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: 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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Niacin reaction test
Time Frame: 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.
During the intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Jin Wang, Phd, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFMMUChina_NSRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets generated during and/or analysed during the current study will be available upon request from Jin Wang, sciaking@yeah.net

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder

Clinical Trials on Niacin skin reaction test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe