Depressive DisorderNCT06382532
Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT)
An observational study of Depressive Disorder and Malingering, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Malingering
- What is being tested?
- Niacin skin reaction test
- Type of treatment
- Injection or infusion
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 1. Depressive Disorder Malinger Group 2. Depressive Disorder Group 3. Healthy Control Group
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- History of traumatic brain injury;
- Continuous use of non-steroidal anti-inflammatory drugs within the last two weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Air Force Medical Center
Beijing, Beijing Municipality, 100142
Jin Wang
About this study
Official title: 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.
Read the 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
- Being tested
- Niacin skin reaction test
- Medical subject headings
- Depressive Disorder, Malingering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin skin reaction testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Niacin skin reaction test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intervention
Secondary outcomes (2)
Model specificity and sensitivity
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.
Measured: Through study completion, an average of 2 years
The F Scale in Minnesota Multiphasic Personality Inventory
The F Scale in Minnesota Multiphasic Personality Inventory (MMPI) is used to detect attempts at fraud.
Measured: Baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 410 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wang, Air Force Military Medical University, China
- Investigators
- Jin Wang, Phd, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382532
- Sponsor's protocol ID
- AFMMUChina_NSRT
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analysed during the current study will be available upon request from Jin Wang, sciaking@yeah.net
Publications
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.
PubMed 33677199Ward 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.
PubMed 9516668Sun 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.
PubMed 29077970Messamore 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.
PubMed 20417059Wang 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.
PubMed 36521667
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Diagnostic Techniques for the Diagnosis of Depressive Disorders Malinger Based on the Niacin Skin Response Test (NSRT)
- ClinicalTrials.gov ID
- NCT06382532
- Acronym / sponsor ID
- AFMMUChina_NSRT
- Conditions
- Depressive Disorder, Malingering
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | Diagnostic Test: Niacin skin reaction test1. 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. |
| Depressive disorder group | – | Diagnostic Test: Niacin skin reaction test1. Patients with a first depressive disorder meeting DSM-5 criteria; 2. Age 18-60 years, Males; 3. Voluntary informed consent. |
| Depressive disorder malinger group | – | Diagnostic Test: Niacin skin reaction test1. 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Depressive Disorder Malinger Group 2. Depressive Disorder Group 3. Healthy Control Group
Key inclusion criteria (15 listed)
- 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.
- Patients with a first depressive disorder meeting DSM-5 criteria;
Key exclusion criteria (2 listed)
- History of traumatic brain injury;
- Continuous use of non-steroidal anti-inflammatory drugs within the last two weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin skin reaction testNicotinic 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. | Diagnostic test | Depressive disorder group, Depressive disorder malinger group, Healthy control group |
Primary outcome
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.
2 secondary outcomes
Model specificity and sensitivity
Time frame: Through study completion, an average of 2 years
The F Scale in Minnesota Multiphasic Personality Inventory
Time frame: Baseline, pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 33677199Wang 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.
- Background: PubMed 9516668Ward 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.
- Background: PubMed 29077970Sun 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.
- Background: PubMed 20417059Messamore 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.
- Results publication: PubMed 36521667Wang 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.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analysed during the current study will be available upon request from Jin Wang, sciaking@yeah.net
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Wang, Phd principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Malingering, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Wang, Phd (15321000722, sciaking@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Niacin reaction test (time frame: During the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382532, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.