LRFN5 and OLFM4 in Bipolar Disorder

NCT07434414 | Completed DMC

• 1 other identifier: EMHDH-2025-2026-BD-LRFN5-OLFM4
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional observational case-control study evaluated serum levels of leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and olfactomedin-4 (OLFM4) in subjects with bipolar disorder (BD) during acute manic episodes and in healthy controls (HC). The study also assessed systemic inflammation using the Aggregate Index of Systemic Inflammation (AISI) and examined associations between biomarkers and clinical symptom severity, including Young Mania Rating Scale (YMRS) and Beck Depression Inventory (BDI) scores. The study aimed to investigate the potential interaction between synaptic dysregulation and immunoinflammatory abnormalities in BD.

Conditions

Bipolar Disorder (BD)

Keywords

Bipolar Disorder; LRFN5; OLFM4; Olfactomedin 4; Synaptic Regulation; Systemic Inflammation; Mania

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)

• Young Mania Rating Scale (YMRS)

  At hospital admission (baseline)

• Beck Depression Inventory (BDI)

  At hospital admission (baseline)

Study Arms (2)

Bipolar Disorder (BD)

Adult participants (18-65 years) diagnosed with BD 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 BD group included the Young Mania Rating Scale and Beck Depression Inventory. Sociodemographic and clinical data were recorded for all participants.

Healthy Control (HC)

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.

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 consisted of adult participants aged 18-65 years. The bipolar disorder (BD) group included consecutive patients diagnosed with BD 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.

You may qualify if:

• Diagnosis of BD 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 Bipolar Disorder (BD) 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 BD
• 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

Bipolar Disorder; Mania

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start: July 7, 2025
• Primary Completion: January 2, 2026
• Study Completion: January 2, 2026
• Last Updated: February 25, 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)