Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:20 AM
Study NCT ID:
NCT07447960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LRFN5 and OLFM4 in Schizoaffective Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5)', 'timeFrame': 'At hospital admission (baseline)', 'description': 'Serum leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) levels measured by ELISA (pg/ml)'}, {'measure': 'Olfactomedin-4 (OLFM4)', 'timeFrame': 'At hospital admission (baseline)', 'description': 'Serum olfactomedin-4 (OLFM4) levels measured by ELISA (pg/ml)'}], 'secondaryOutcomes': [{'measure': 'Aggregate Index of Systemic Inflammation (AISI)', 'timeFrame': 'At hospital admission (baseline)', 'description': '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.'}, {'measure': 'Positive and Negative Syndrome Scale (PANSS) Score', 'timeFrame': 'At hospital admission (baseline)', 'description': "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."}, {'measure': 'Young Mania Rating Scale (YMRS)', 'timeFrame': 'At hospital admission (baseline)', 'description': "YMRS comprises 11 items, each rated across five levels of severity. Items 5, 6, 8, and 9 are weighted more heavily to enhance the assessment of patients with communication difficulties. The scale is administered by an experienced clinician through a structured interview lasting approximately 15-30 minutes. Severity ratings are determined based on the patient's subjective reports over the preceding 48 hours, together with the clinician's observations of behavior during the interview."}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'At hospital admission (baseline)', 'description': "The questionnaire is a self-report instrument, and its outcomes are inherently relative, reflecting the respondent's answers to each item. It consists of 21 items and is among the most widely used screening tools for the identification of depressive symptoms. The measure is suitable for use in adults, adolescents, and individuals with psychiatric disorders aged 13 years and older. It is intended to capture a range of depressive symptoms experienced during the preceding week. Each item is rated on a 4-point Likert scale, with response options scored from 0 to 3."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizoaffective Disorder', 'LRFN5', 'OLFM4', 'Biomarkers', 'Neuroinflammation'], 'conditions': ['Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Schizoaffective disorder (SAD) is a chronic psychiatric condition characterized by psychotic and mood symptoms. 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 SAD have not been well characterized. 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). A total of 60 subjects with SAD (30 females, 30 males) and 60 (30 females, 30 males) age- and gender-matched healthy controls will be recruited. Blood samples will be collected after 12-hour fasting and serum levels of LRFN5 and OLFM4 will be measured using ELISA kits. The diagnosis of SAD will be made according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). All subjects diagnosed with SAD will be included in the study during the acute manic episode phase (immediately before hospitalization).The healthy control group will consist of individuals without current or past psychiatric disorders and without significant medical illnesses. None of the participants will have chronic inflammatory, autoimmune, neurological, or systemic diseases. Venous blood samples will be collected at hospital admission prior to initiation of pharmacological treatment in the SAD group. Serum will be separated and stored at -80°C until analysis. Serum LRFN5 and OLFM4 levels will be measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits in accordance with the manufacturer's instructions. Routine complete blood count parameters will be obtained, and the Aggregate Index of Systemic Inflammation (AISI) will be calculated as: (neutrophils × monocytes × platelets) / lymphocytes. Clinical assessments in the SAD group will be include the Positive and Negative Syndrome Scale (PANSS) for psychotic symptom severity, Young Mania Rating Scale (YMRS) for manic symptom severity, and Beck Depression Inventory (BDI) for depressive symptom severity. Sociodemographic and clinical data will be recorded for all participants. The primary objective was to compare circulating LRFN5 and OLFM4 levels between SAD and healthy control groups. Secondary objectives included evaluating associations between these biomarkers and symptom severity 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: 2025/09-09) and was conducted in accordance with the Declaration of Helsinki. All participants will provide written informed consent prior to participation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': '1. For Schizoaffective Disorder (SAD) Group:\n\n \\*Inclusion Criteria:\n * Diagnosis of SAD according to DSM-5-TR\n * Acute manic episode\n * Medication-free for at least one month prior to admission\n * Age ≥ 18 years and \\<65 years\n * Provided informed consent\n\n For Schizoaffective Disorder (SAD) Group:\n\n \\*Exclusion Criteria:\n\n • Hypertension\n\n • Diabetes mellitus\n\n • Chronic kidney disease\n\n • Rheumatoid arthritis\n\n • Systemic lupus erythematosus\n\n • Cardiac illness\n\n • Severe neurological disorders\n\n • Immunological or systemic illness\n\n • Primary psychiatric disorders other than SAD\n * Alcohol/drug/substance use\n2. For Healthy Control Group:\n\n \\*Inclusion Criteria:\n\n • No psychiatric diagnosis\n\n • No systemic or immunological illness\n * Medication-free for at least one month\n * Age ≥ 18 years and \\< 65 years\n * Provided informed consent\n\nFor Healthy Control Group:\n\n\\*Exclusion Criteria:\n\n* Hypertension\n* Diabetes mellitus\n* Chronic kidney disease\n* Rheumatoid arthritis\n* Systemic lupus erythematosus\n* Cardiac illness\n* Severe neurological disorders\n* Immunological or systemic illness\n* Having psychiatric disorders\n* Alcohol/drug/substance use'}, 'identificationModule': {'nctId': 'NCT07447960', 'briefTitle': 'LRFN5 and OLFM4 in Schizoaffective Disorder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Elazığ Mental Health and Diseases Hospital'}, 'officialTitle': 'LRFN5 and OLFM4 Levels in Schizoaffective Disorder: A Cross-Sectional Case-Control Study', 'orgStudyIdInfo': {'id': 'EMHDH-2026-SAD-LRFN5-OLFM4-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Schizoaffective Disorder (SAD)', 'description': '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.'}, {'label': 'Healthy Control (HC)', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23200', 'city': 'Elâzığ', 'state': 'Elâzığ', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist', 'role': 'CONTACT', 'email': 'mhorum@hotmail.com', 'phone': '+905382207558'}], 'facility': 'Elazığ Mental Health and Diseases Hospital Psychiatry Clinic', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'centralContacts': [{'name': 'Mehmet Hamdi ÖRÜM, MD, Assoc Prof, Psychiatrist', 'role': 'CONTACT', 'email': 'mhorum@hotmail.com', 'phone': '+905382207558'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning 6 months after publication and will remain available for 5 years.', 'ipdSharing': 'YES', 'description': '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, Positive and Negative Syndrome Scale (PANSS) for psychotic symptom severity, Young Mania Rating Scale (YMRS) for manic symptom severity, and the Beck Depression Inventory (BDI) for depressive symptoms\\] 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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elazığ Mental Health and Diseases Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD, Psychiatrist', 'investigatorFullName': 'Mehmet Hamdi ÖRÜM', 'investigatorAffiliation': 'Elazığ Mental Health and Diseases Hospital'}}}}