LRFN5 and OLFM4 in Schizoaffective Disorder

NCT07447960 | Not Yet Recruiting DMC

• 1 other identifier: EMHDH-2026-SAD-LRFN5-OLFM4-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Schizoaffective disorder (SAD) is a chronic psychiatric condition characterized by psychotic and mood symptoms. Emerging evidence suggests that Leucine-Rich Repeat and Fibronectin Type-III Domain-Containing Protein 5 (LRFN5) and olfactomedin-4 (OLFM4) may play roles in synaptic organization, neurodevelopment, and neuroinflammation. However, no prior study has investigated these biomarkers in SAD. This cross-sectional case-control study aims to compare peripheral serum levels of LRFN5 and OLFM4 in subjects diagnosed with SAD in remission and healthy control subjects. 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 SAD.

Conditions

Schizoaffective Disorder

Keywords

Schizoaffective Disorder; LRFN5; OLFM4; Biomarkers; Neuroinflammation

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 (4)

• Aggregate Index of Systemic Inflammation (AISI)

  At hospital admission (baseline)

• Positive and Negative Syndrome Scale (PANSS) Score

  At hospital admission (baseline)

• Young Mania Rating Scale (YMRS)

  At hospital admission (baseline)

• Beck Depression Inventory (BDI)

  At hospital admission (baseline)

Study Arms (2)

Schizoaffective Disorder (SAD)

Adult participants (18-65 years) with schizoaffective disorder according to DSM-5-TR criteria. Participants will be evaluated at baseline. No intervention will be assigned by the study protocol. Blood samples will be collected for the measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters. Clinical assessments in the schizophrenia group will include the Positive and Negative Syndrome Scale (PANSS) for psychotic symptom severity, the Young Mania Rating Scale (YMRS) for manic symptom severity, and the Beck Depression Inventory (BDI) for depressive symptom severity. Sociodemographic and clinical data will be recorded for all participants.

Healthy Control (HC)

Healthy control adult participants (18-65 years) without any current or past psychiatric disorder will be enrolled in the study. No intervention will be administered as part of the research protocol. Participants will undergo a baseline clinical evaluation and will provide a single blood sample for measurement of serum LRFN5 and OLFM4 levels and complete blood count parameters.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult participants aged 18-65 years. The schizoaffective disorder (SAD) group will include consecutive subjects diagnosed with SAD according to DSM-5-TR criteria who will be admitted to the psychiatry clinic of Elazığ Mental Health and Diseases Hospital (Turkey). The healthy control (HC) group will consist of individuals from the general population who will apply to the hospital medical board and will have no current or past psychiatric or significant medical disorders. All participants will provide informed consent prior to enrollment.

You may qualify if:

• Diagnosis of SAD according to DSM-5-TR
• Acute manic episode
• Medication-free for at least one month prior to admission
• Age ≥ 18 years and \<65 years
• Provided informed consent
• For Schizoaffective Disorder (SAD) 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 SAD
• Alcohol/drug/substance use
• For Healthy Control Group:
• No psychiatric diagnosis
• No systemic or immunological illness
• Medication-free for at least one month
• Age ≥ 18 years and \< 65 years

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Elazığ Mental Health and Diseases Hospital Psychiatry Clinic

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychotic Disorders; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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, MD, Psychiatrist

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: March 2, 2026
• Primary Completion: May 29, 2026
• Study Completion: May 29, 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)