Methamphetamine Use DisorderNCT07450027
LRFN5 and OLFM4 in Methamphetamine-Induced Psychosis
An observational study of Methamphetamine Use Disorder and Methamphetamine-induced Psychosis, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational case-control study aimed to examined serum levels of leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and olfactomedin-4 (OLFM4) levels in methamphetamine use disorder (MUD), methamphetamine-induced psychotic disorder (MP), and healthy control (HC)… Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Use Disorder, Methamphetamine-induced Psychosis
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Apr 2026
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study population consisted/will be consisted of adult male inpatients aged 18-65 years who were admitted to Elazığ Mental Health and Diseases Hospital. The MP group included/will include consecutive inpatients diagnosed with methamphetamine-induced psychotic disorder (MP) and the methamphetamine use disorder (MUD) group included/will include consecutive inpatients diagnosed with MUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Both patient groups consisted of active methamphetamine users and were hospitalized for clinical management at the time of assessment. Urine toxicology screening was performed at admission to confirm substance use status. The Healthy Control (HC) group consisted of adult male individuals without current or past psychiatric disorders and without substance use disorders, matched to patient groups in terms of age and body mass index. HCs had no significant medical illnesses.
Who may be able to join
- Diagnosis of MUD according to DSM-5-TR
- Medication-free for at least one month prior to admission
- Age ≥ 18 years and <65 years
- Provided informed consent
- For Methamphetamine Use Disorder (MUD) Group:
- Diagnosis of MP according to DSM-5-TR
Show all 16Show fewer
- Medication-free for at least one month prior to admission
- Age ≥ 18 years and <65 years
- Provided informed consent
- For Methamphetamine-Induced Psychotic Disorder (MP) Group:
- No psychiatric diagnosis
- No systemic or immunological illness
- Medication-free for at least one month
- Age ≥ 18 years and <65 years
- Provided informed consent
- For Healthy Control Group:
Who cannot join
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
Show all 32Show fewer
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than MUD
- Alcohol use disorder
- For Methamphetamine-Induced Psychotic Disorder (MP) Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than MP
- Alcohol use disorder
- For Healthy Control Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than schizophrenia
- Alcohol/drug/substance use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Mental Health and Diseases Hospital
Elâzığ, Elâzığ, 23200
About this study
Official title: Serum LRFN5 and OLFM4 Levels in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Cross-Sectional Case-Control Study
This cross-sectional observational case-control study aimed to examined serum levels of leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and olfactomedin-4 (OLFM4) levels in methamphetamine use disorder (MUD), methamphetamine-induced psychotic disorder (MP), and healthy control (HC) groups. The study also aimed to assessed systemic inflammation using the Aggregate Index of Systemic Inflammation (AISI) and examined associations between biomarkers and clinical symptom severity, including Insight Assessment Scale (IAS) and Positive and Negative Syndrome Scale (PANSS) scores.
Read the detailed description
Methamphetamine is a potent central nervous system stimulant associated with addiction, neurotoxicity, and increased risk of psychosis. Chronic exposure affects dopaminergic systems in the mesolimbic and striatal pathways, potentially contributing to sensitization and psychotic symptom development. Methamphetamine-induced psychotic disorder (MP) occurs in a substantial proportion of users, yet individual vulnerability varies. Biological markers that may predict psychosis in methamphetamine users remain insufficiently studied.
Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) is a transmembrane synaptic adhesion molecule involved in synapse development, plasticity, and neuroimmune regulation. It contributes to excitatory and inhibitory synaptic differentiation and may influence neuroinflammatory responses. Olfactomedin-4 (OLFM4) is a neutrophil-specific glycoprotein involved in innate immunity, apoptosis regulation, inflammation, and glutamatergic synaptic modulation. These two markers are located in relatively close chromosomal regions and may demonstrate coordinated biological behavior.
To date, LRFN5 and OLFM4 have not been investigated in methamphetamine use disorder (MUD) or MP. This study is designed to compare serum levels of LRFN5 and OLFM4 among subjects with MP, subjects with MUD, and healthy controls (HC) subjects. A secondary objective was to evaluate associations between LRFN5, OLFM4 levels, psychotic symptom severity, and systemic inflammation, and to assess its potential predictive value for MP diagnosis.
Participants were planned to be consecutive inpatients diagnosed with MUD or MP according to the American Psychiatric Association's Fifth Edition Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR). Participant recruitment began on September 1, 2025, and is planned to be completed on April 1, 2026. All patients were selected/will be selected from those admitted to Elazığ Mental Health and Diseases Hospital. The HC group consisted of individuals without current or past psychiatric disorders or significant medical illnesses. Adult male participants aged 18-65 were included.
Venous blood samples were collected/will be collected at hospital admission prior to initiation of treatment. Samples were/will be centrifuged within 30 minutes and serum was stored at -80°C until analysis. Serum LRFN5 and OLFM4 levels were/will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Routine biochemical analyses and urine toxicology screening were/will be also performed. The Aggregate Index of Systemic Inflammation (AISI) was/will be calculated as (neutrophils × monocytes × platelets) / lymphocytes.
Psychotic symptom severity in the MP group was/will be assessed using the Positive and Negative Syndrome Scale (PANSS). Insight in the MP group was/will be assessed using the Insight Assessment Scale (IAS). Sociodemographic variables and clinical characteristics, including self-mutilation history, drug use onset age, duration of methamphetamine use, and smoking status were/will be recorded.
The study was/will be conducted in accordance with the Declaration of Helsinki and approved by the relevant institutional ethics committee. All participants provided/will provide written informed consent prior to participation.
- Keywords
- LRFN5, OLFM4, Methamphetamine, Psychotic Disorder, Methamphetamine Psychosis, Psychostimulants
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Methamphetamine Use Disorder | Adult participants (18-65 years) diagnosed with Methamphetamine Use Disorder according to DSM-5-TR criteria. Participants were/will be evaluated at hospital admission (baseline). No intervention was/will be assigned by the study protocol. Blood samples were/will be collected for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. No psychometric scales were/will be administered to this group. Sociodemographic and clinical data were/will be recorded for all participants. | |
| Methamphetamine-Induced Psychotic Disorder | Adult participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to DSM-5-TR criteria. Participants were/will be evaluated at hospital admission (baseline). No intervention was/will be assigned by the study protocol. Blood samples were/will be collected for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. Psychotic symptom severity was/will be assessed using the Positive and Negative Syndrome Scale (PANSS). Insight Assessment Scale was/will be used to measure the insight level. Sociodemographic and clinical data were/will be recorded for all participants. | |
| Healthy Control | Healthy control adult participants (18-65 years) without any current or past psychiatric disorder. No intervention was administered as part of the research protocol. Participants underwent a baseline clinical evaluation and provided a single blood sample for measurement of serum α-N-acetylgalactosaminidase levels and complete blood count inflammatory markers. Sociodemographic and clinical data were recorded for all participants. As of January 6, 2026, the recruitment of healthy control participants has been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5)
Serum leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) levels measured by ELISA (pg/ml)
Measured: At hospital admission (baseline)
Olfactomedin-4 (OLFM4)
Serum olfactomedin-4 (OLFM4) levels measured by ELISA (pg/ml)
Measured: At hospital admission (baseline)
Secondary outcomes (3)
Aggregate Index of Systemic Inflammation (AISI)
Aggregate Index of Systemic Inflammation (AISI) is calculated using the following formula: (neutrophils × monocytes × platelets) / (lymphocytes). All the parameters mentioned here are complete blood count parameters.
Measured: At hospital admission (baseline)
Positive and Negative Syndrome Scale (PANSS) Score
Positive and Negative Syndrome Scale (PANSS) was developed to assess positive and negative symptoms and general psychopathology in patients with schizophrenia-spectrum disorder, and to measure the level of these symptoms. It is administered via a semi-structured interview, taking into account the last week. Information can also be obtained from the patient's relatives and healthcare staff. It consists of a total of 30 items: 7 items addressing positive symptoms, 7 addressing negative symptoms, and 16 addressing general psychopathology symptoms. Each item is scored from 1 to 7, and the scores are summed for the final score. This scale was only administered to the methamphetamine-induced psychotic disorder group.
Measured: At hospital admission (baseline)
Insight Assessment Scale (IAS)
It was reported that insight cannot be evaluated as either present or absent, and it was defined it as a three-way process consisting of compliance with treatment, awareness of the illness, and accurate recognition of psychotic experiences. Based on these components, Insight Assessment Scale (IAS) was developed as a clinician-administered scale that quantitatively assesses insight for individuals with psychosis. IAS is an 8-question, clinician-administered, semi-structured scale. "Treatment acceptance"(1a), " treatmentrequest" (1b), "knowledge of illness" (2a), "knowledge of mental illness" (2b), "explanation of illness" (2c), "In addition to the 7 subscales titled "believing in the truth of the delusion" (3a), "explaining their experiences" (3b), there is a subscale titled "reaction to disbelief". The highest total score with this question is 18. A high score indicates a high level of insight.
Measured: At hospital admission (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Sep 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazığ Mental Health and Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Hamdi ÖRÜM, Elazığ Mental Health and Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450027
- Sponsor's protocol ID
- EMHDH-2025/26-METH-LRFN5-OLFM4
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the results reported in this study \[including demographic variables, serum leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and Olfactomedin-4 (OLFM4) levels, complete blood count parameters, and Positive and Negative Syndrome Scale (PANSS) and Insight Assessment Scale (IAS)\] will be made available to qualified researchers upon reasonable request for academic purposes. Data will be shared after removal of all direct identifiers and in accordance with applicable ethical approvals and data protection regulations. Access to the data will require a methodologically sound research proposal and a data use agreement. Requests should be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum LRFN5 and OLFM4 Levels in Methamphetamine Use Disorder and Methamphetamine-Induced Psychotic Disorder: A Cross-Sectional Case-Control Study
- ClinicalTrials.gov ID
- NCT07450027
- Acronym / sponsor ID
- EMHDH-2025/26-METH-LRFN5-OLFM4
- Keywords
- LRFN5, OLFM4, Methamphetamine, Psychotic Disorder, Methamphetamine Psychosis, Psychostimulants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 4 Mar 2026 (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 cross-sectional observational case-control study aimed to examined serum levels of leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and olfactomedin-4 (OLFM4) levels in methamphetamine use disorder (MUD), methamphetamine-induced psychotic disorder (MP), and healthy control (HC) groups. The study also aimed to assessed systemic inflammation using the Aggregate Index of Systemic Inflammation (AISI) and examined associations between biomarkers and clinical symptom severity, including Insight Assessment Scale (IAS) and Positive and Negative Syndrome Scale (PANSS) scores.
Detailed description
Methamphetamine is a potent central nervous system stimulant associated with addiction, neurotoxicity, and increased risk of psychosis. Chronic exposure affects dopaminergic systems in the mesolimbic and striatal pathways, potentially contributing to sensitization and psychotic symptom development. Methamphetamine-induced psychotic disorder (MP) occurs in a substantial proportion of users, yet individual vulnerability varies. Biological markers that may predict psychosis in methamphetamine users remain insufficiently studied.
Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) is a transmembrane synaptic adhesion molecule involved in synapse development, plasticity, and neuroimmune regulation. It contributes to excitatory and inhibitory synaptic differentiation and may influence neuroinflammatory responses. Olfactomedin-4 (OLFM4) is a neutrophil-specific glycoprotein involved in innate immunity, apoptosis regulation, inflammation, and glutamatergic synaptic modulation. These two markers are located in relatively close chromosomal regions and may demonstrate coordinated biological behavior.
To date, LRFN5 and OLFM4 have not been investigated in methamphetamine use disorder (MUD) or MP. This study is designed to compare serum levels of LRFN5 and OLFM4 among subjects with MP, subjects with MUD, and healthy controls (HC) subjects. A secondary objective was to evaluate associations between LRFN5, OLFM4 levels, psychotic symptom severity, and systemic inflammation, and to assess its potential predictive value for MP diagnosis.
Participants were planned to be consecutive inpatients diagnosed with MUD or MP according to the American Psychiatric Association's Fifth Edition Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR). Participant recruitment began on September 1, 2025, and is planned to be completed on April 1, 2026. All patients were selected/will be selected from those admitted to Elazığ Mental Health and Diseases Hospital. The HC group consisted of individuals without current or past psychiatric disorders or significant medical illnesses. Adult male participants aged 18-65 were included.
Venous blood samples were collected/will be collected at hospital admission prior to initiation of treatment. Samples were/will be centrifuged within 30 minutes and serum was stored at -80°C until analysis. Serum LRFN5 and OLFM4 levels were/will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Routine biochemical analyses and urine toxicology screening were/will be also performed. The Aggregate Index of Systemic Inflammation (AISI) was/will be calculated as (neutrophils × monocytes × platelets) / lymphocytes.
Psychotic symptom severity in the MP group was/will be assessed using the Positive and Negative Syndrome Scale (PANSS). Insight in the MP group was/will be assessed using the Insight Assessment Scale (IAS). Sociodemographic variables and clinical characteristics, including self-mutilation history, drug use onset age, duration of methamphetamine use, and smoking status were/will be recorded.
The study was/will be conducted in accordance with the Declaration of Helsinki and approved by the relevant institutional ethics committee. All participants provided/will provide written informed consent prior to participation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methamphetamine Use Disorder | – | –Adult participants (18-65 years) diagnosed with Methamphetamine Use Disorder according to DSM-5-TR criteria. Participants were/will be evaluated at hospital admission (baseline). No intervention was/will be assigned by the study protocol. Blood samples were/will be collected for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. No psychometric scales were/will be administered to this group. Sociodemographic and clinical data were/will be recorded for all participants. |
| Methamphetamine-Induced Psychotic Disorder | – | –Adult participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to DSM-5-TR criteria. Participants were/will be evaluated at hospital admission (baseline). No intervention was/will be assigned by the study protocol. Blood samples were/will be collected for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. Psychotic symptom severity was/will be assessed using the Positive and Negative Syndrome Scale (PANSS). Insight Assessment Scale was/will be used to measure the insight level. Sociodemographic and clinical data were/will be recorded for all participants. |
| Healthy Control | – | –Healthy control adult participants (18-65 years) without any current or past psychiatric disorder. No intervention was administered as part of the research protocol. Participants underwent a baseline clinical evaluation and provided a single blood sample for measurement of serum α-N-acetylgalactosaminidase levels and complete blood count inflammatory markers. Sociodemographic and clinical data were recorded for all participants. As of January 6, 2026, the recruitment of healthy control participants has been completed. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted/will be consisted of adult male inpatients aged 18-65 years who were admitted to Elazığ Mental Health and Diseases Hospital. The MP group included/will include consecutive inpatients diagnosed with methamphetamine-induced psychotic disorder (MP) and the methamphetamine use disorder (MUD) group included/will include consecutive inpatients diagnosed with MUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Both patient groups consisted of active methamphetamine users and were hospitalized for clinical management at the time of assessment. Urine toxicology screening was performed at admission to confirm substance use status. The Healthy Control (HC) group consisted of adult male individuals without current or past psychiatric disorders and without substance use disorders, matched to patient groups in terms of age and body mass index. HCs had no significant medical illnesses.
Key inclusion criteria (16 listed)
Key exclusion criteria (32 listed)
- For Methamphetamine-Induced Psychotic Disorder (MP) Group:
- For Healthy Control Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5)
Time frame: At hospital admission (baseline)
Serum leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) levels measured by ELISA (pg/ml)
Olfactomedin-4 (OLFM4)
Time frame: At hospital admission (baseline)
Serum olfactomedin-4 (OLFM4) levels measured by ELISA (pg/ml)
3 secondary outcomes
Aggregate Index of Systemic Inflammation (AISI)
Time frame: At hospital admission (baseline)
Positive and Negative Syndrome Scale (PANSS) Score
Time frame: At hospital admission (baseline)
Insight Assessment Scale (IAS)
Time frame: At hospital admission (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the results reported in this study [including demographic variables, serum leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and Olfactomedin-4 (OLFM4) levels, complete blood count parameters, and Positive and Negative Syndrome Scale (PANSS) and Insight Assessment Scale (IAS)] will be made available to qualified researchers upon reasonable request for academic purposes. Data will be shared after removal of all direct identifiers and in accordance with applicable ethical approvals and data protection regulations. Access to the data will require a methodologically sound research proposal and a data use agreement. Requests should be directed to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Methamphetamine Use Disorder and Methamphetamine-induced Psychosis, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
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 16 inclusion and 32 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: finished, as of the sponsor's last update on 10 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) (time frame: At hospital admission (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.