Schizophrenia DisorderNCT07434388
LRFN5 and OLFM4 in Schizophrenia
An observational study of Schizophrenia Disorder, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study evaluated serum levels of Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and Olfactomedin-4 (OLFM4) in patients with schizophrenia during acute exacerbation and in healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorder
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2025to 1 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of adult participants aged 18-65 years. The Schizophrenia group included consecutive patients diagnosed with schizophrenia according to DSM-5-TR criteria who were admitted to the psychiatry clinic of Elazığ Mental Health and Diseases Hospital (Turkey). The healthy control (HC) group consisted of individuals from the general population who applied to the hospital medical board and had no current or past psychiatric or significant medical disorders. All participants provided informed consent prior to enrollment.
Who may be able to join
- Diagnosis of schizophrenia according to DSM-5-TR
- Acute exacerbation requiring hospitalization
- Medication-free for at least one month prior to admission
- Age ≥ 18 years and <65 years
- Provided informed consent
- For Schizophrenia Group:
Show all 12Show fewer
- 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 21Show fewer
- Severe neurological disorders
- Immunological or systemic illness
- Primary psychiatric disorders other than schizophrenia
- Alcohol/drug/substance use
- 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 Psychiatry Clinic
Elâzığ, Elâzığ, 23200
About this study
Official title: Low Levels of LRFN5 and OLFM4 in Schizophrenia May Be Associated With Synaptic Regulation and Immunoinflammatory Abnormalities
This cross-sectional observational study evaluated serum levels of Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and Olfactomedin-4 (OLFM4) in patients with schizophrenia during acute exacerbation and in healthy controls. The study also assessed associations between these biomarkers and clinical symptom severity, global functioning, and systemic inflammation measured by the Aggregate Index of Systemic Inflammation (AISI). The study aimed to investigate convergent synaptic and immunoinflammatory dysregulation in schizophrenia.
Read the detailed description
Schizophrenia is increasingly conceptualized as a disorder characterized by synaptic dysfunction and immune-inflammatory dysregulation. Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5), also known as synaptic adhesion-like molecule 5 (SALM5), is a postsynaptic adhesion molecule involved in synapse formation, maturation, and stabilization, particularly within glutamatergic pathways. Olfactomedin-4 (OLFM4) is a secreted glycoprotein expressed in neutrophils and other immune cells and is involved in apoptotic regulation and inflammatory processes. Although both molecules have biological relevance to neurodevelopmental and immune mechanisms, their circulating levels in schizophrenia have not been well characterized.
This cross-sectional observational study aimed to compare serum LRFN5 and OLFM4 levels between subjects with schizophrenia during acute exacerbation and healthy control (HC) subjects, and to examine their associations with clinical symptom severity, global functioning, and systemic inflammation.
The study included 60 adult participants aged 18-65 years. The schizophrenia group consisted of consecutive inpatients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). All patients were hospitalized during an acute exacerbation and had not received psychotropic medication for at least one month prior to admission. The HC group consisted of individuals without current or past psychiatric disorders and without significant medical illnesses. None of the participants had chronic inflammatory, autoimmune, neurological, or systemic diseases.
Venous blood samples were collected at hospital admission prior to initiation of pharmacological treatment in the schizophrenia group. Serum was separated and stored at -80°C until analysis. Serum LRFN5 and OLFM4 levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits in accordance with the manufacturer's instructions. Routine complete blood count parameters were obtained, and the Aggregate Index of Systemic Inflammation (AISI) was calculated as: (neutrophils × monocytes × platelets) / lymphocytes.
Clinical assessments in the schizophrenia group included the Positive and Negative Syndrome Scale (PANSS) for symptom severity and the Global Assessment Scale (GAS) for overall functioning. Sociodemographic and clinical data were recorded for all participants.
The primary objective was to compare circulating LRFN5 and OLFM4 levels between schizophrenia and healthy control groups. Secondary objectives included evaluating associations between these biomarkers and symptom severity, global functioning, and systemic inflammation indices, as well as assessing their potential diagnostic performance using logistic regression and receiver operating characteristic (ROC) analyses.
The study was approved by the Fırat University Non-invasive Research Ethics Committee (Approval Number: 2025/07-25) and was conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent prior to participation.
- Conditions
- Schizophrenia Disorder
- Keywords
- Schizophrenia, LRFN5, OLFM4, Olfactomedin 4, Synaptic Regulation, Systemic Inflammation, Biomarkers
- Medical subject headings
- Schizophrenia
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 |
|---|---|---|
| Schizophrenia | Adult participants (18-65 years) diagnosed with schizophrenia according to DSM-5-TR criteria. Participants were evaluated at baseline. No intervention was assigned by the study protocol. Blood samples were collected for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. Clinical assessments in the schizophrenia group included the Positive and Negative Syndrome Scale (PANSS) for symptom severity and the Global Assessment Scale (GAS) for overall functioning. Sociodemographic and clinical data were 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 LRFN5 and OLFM4 levels and complete blood count parameters. |
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.
Measured: At hospital admission (baseline)
Global Assessment Scale (GAS)
The Global Assessment Scale (GAS) is a brief rating instrument designed to evaluate overall functioning by encompassing psychological, social, and occupational domains affected by psychopathology. GAS provides a single global score ranging from 0 to 100.
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 posted25 Feb 2026
- Study start27 Apr 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia 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
- 60 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
- Investigators
- Mehmet Hamdi ÖRÜM, MD, Principal investigator, Elazığ Mental Health and Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434388
- Sponsor's protocol ID
- EMHDH-2025-SCZ-LRFN5-OLFM4-01
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- 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) for symptom severity and the Global Assessment Scale (GAS) for overall functioning) 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Levels of LRFN5 and OLFM4 in Schizophrenia May Be Associated With Synaptic Regulation and Immunoinflammatory Abnormalities
- ClinicalTrials.gov ID
- NCT07434388
- Acronym / sponsor ID
- EMHDH-2025-SCZ-LRFN5-OLFM4-01
- Conditions
- Schizophrenia Disorder
- Keywords
- Schizophrenia, LRFN5, OLFM4, Olfactomedin 4, Synaptic Regulation, Systemic Inflammation, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 25 Feb 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 study evaluated serum levels of Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and Olfactomedin-4 (OLFM4) in patients with schizophrenia during acute exacerbation and in healthy controls. The study also assessed associations between these biomarkers and clinical symptom severity, global functioning, and systemic inflammation measured by the Aggregate Index of Systemic Inflammation (AISI). The study aimed to investigate convergent synaptic and immunoinflammatory dysregulation in schizophrenia.
Detailed description
Schizophrenia is increasingly conceptualized as a disorder characterized by synaptic dysfunction and immune-inflammatory dysregulation. Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5), also known as synaptic adhesion-like molecule 5 (SALM5), is a postsynaptic adhesion molecule involved in synapse formation, maturation, and stabilization, particularly within glutamatergic pathways. Olfactomedin-4 (OLFM4) is a secreted glycoprotein expressed in neutrophils and other immune cells and is involved in apoptotic regulation and inflammatory processes. Although both molecules have biological relevance to neurodevelopmental and immune mechanisms, their circulating levels in schizophrenia have not been well characterized.
This cross-sectional observational study aimed to compare serum LRFN5 and OLFM4 levels between subjects with schizophrenia during acute exacerbation and healthy control (HC) subjects, and to examine their associations with clinical symptom severity, global functioning, and systemic inflammation.
The study included 60 adult participants aged 18-65 years. The schizophrenia group consisted of consecutive inpatients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). All patients were hospitalized during an acute exacerbation and had not received psychotropic medication for at least one month prior to admission. The HC group consisted of individuals without current or past psychiatric disorders and without significant medical illnesses. None of the participants had chronic inflammatory, autoimmune, neurological, or systemic diseases.
Venous blood samples were collected at hospital admission prior to initiation of pharmacological treatment in the schizophrenia group. Serum was separated and stored at -80°C until analysis. Serum LRFN5 and OLFM4 levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits in accordance with the manufacturer's instructions. Routine complete blood count parameters were obtained, and the Aggregate Index of Systemic Inflammation (AISI) was calculated as: (neutrophils × monocytes × platelets) / lymphocytes.
Clinical assessments in the schizophrenia group included the Positive and Negative Syndrome Scale (PANSS) for symptom severity and the Global Assessment Scale (GAS) for overall functioning. Sociodemographic and clinical data were recorded for all participants.
The primary objective was to compare circulating LRFN5 and OLFM4 levels between schizophrenia and healthy control groups. Secondary objectives included evaluating associations between these biomarkers and symptom severity, global functioning, and systemic inflammation indices, as well as assessing their potential diagnostic performance using logistic regression and receiver operating characteristic (ROC) analyses.
The study was approved by the Fırat University Non-invasive Research Ethics Committee (Approval Number: 2025/07-25) and was conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent prior to participation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | –Adult participants (18-65 years) diagnosed with schizophrenia according to DSM-5-TR criteria. Participants were evaluated at baseline. No intervention was assigned by the study protocol. Blood samples were collected for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. Clinical assessments in the schizophrenia group included the Positive and Negative Syndrome Scale (PANSS) for symptom severity and the Global Assessment Scale (GAS) for overall functioning. Sociodemographic and clinical data were 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 LRFN5 and OLFM4 levels and complete blood count parameters. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult participants aged 18-65 years. The Schizophrenia group included consecutive patients diagnosed with schizophrenia according to DSM-5-TR criteria who were admitted to the psychiatry clinic of Elazığ Mental Health and Diseases Hospital (Turkey). The healthy control (HC) group consisted of individuals from the general population who applied to the hospital medical board and had no current or past psychiatric or significant medical disorders. All participants provided informed consent prior to enrollment.
Key inclusion criteria (12 listed)
- Diagnosis of schizophrenia according to DSM-5-TR
- Acute exacerbation requiring hospitalization
- Medication-free for at least one month prior to admission
- Age ≥ 18 years and <65 years
- Provided informed consent
Key exclusion criteria (21 listed)
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
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)
Global Assessment Scale (GAS)
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 25 Feb 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) for symptom severity and the Global Assessment Scale (GAS) for overall functioning) 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.
Mehmet Hamdi ÖRÜM, MD principal investigator
Elazığ Mental Health and Diseases Hospital
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 Schizophrenia Disorder, 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 12 inclusion and 21 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 25 Feb 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 25 Feb 2026.