LRFN5 and OLFM4 in Methamphetamine-Induced Psychosis

NCT07450027 | Recruiting DMC

• 1 other identifier: EMHDH-2025/26-METH-LRFN5-OLFM4
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Methamphetamine Use Disorder; Methamphetamine-induced Psychosis

Keywords

LRFN5; OLFM4; Methamphetamine; Psychotic Disorder; Methamphetamine Psychosis; Psychostimulants

Outcome Measures

Primary Outcomes (2)

• 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)

  At hospital admission (baseline)

• Olfactomedin-4 (OLFM4)

  Serum olfactomedin-4 (OLFM4) levels measured by ELISA (pg/ml)

  At hospital admission (baseline)

Secondary Outcomes (3)

• Aggregate Index of Systemic Inflammation (AISI)

  At hospital admission (baseline)

• Positive and Negative Syndrome Scale (PANSS) Score

  At hospital admission (baseline)

• Insight Assessment Scale (IAS)

  At hospital admission (baseline)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:

You may not qualify if:

• 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 MUD
• Alcohol use disorder
• For Methamphetamine-Induced Psychotic Disorder (MP) Group:
• Diagnosis of MP according to DSM-5-TR
• Medication-free for at least one month prior to admission
• Age ≥ 18 years and \<65 years
• Provided informed consent

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Elazığ Mental Health and Diseases Hospital

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist

CONTACT

+905382207558; mhorum@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Mehmet Hamdi Örüm, MD, Psychiatrist

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal. Requests must be approved by the principal investigator and may require a data use agreement in accordance with institutional and ethical regulations.

Locations

TU (1)