Schizoaffective DisorderNCT07447960
LRFN5 and OLFM4 in Schizoaffective Disorder
An observational study of Schizoaffective Disorder, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizoaffective Disorder
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 2 Jun 2026
- 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 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.
Who may be able to join
- 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:
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 SAD
- 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
- Having psychiatric disorders
- 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: LRFN5 and OLFM4 Levels in Schizoaffective Disorder: A Cross-Sectional Case-Control Study
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.
Read the detailed description
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.
- Conditions
- Schizoaffective Disorder
- Keywords
- Schizoaffective Disorder, LRFN5, OLFM4, Biomarkers, Neuroinflammation
- Medical subject headings
- Psychotic Disorders, Neuroinflammatory Diseases
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 |
|---|---|---|
| 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. |
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 (4)
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)
Young Mania Rating Scale (YMRS)
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.
Measured: At hospital admission (baseline)
Beck Depression Inventory (BDI)
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.
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 posted4 Mar 2026
- Study start2 Mar 2026
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective 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
- 110 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447960
- Sponsor's protocol ID
- EMHDH-2026-SAD-LRFN5-OLFM4-01
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the results reported in this study \[including demographic variables, serum leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and Olfactomedin-4 (OLFM4) levels, complete blood count parameters, Positive and Negative Syndrome Scale (PANSS) for psychotic symptom severity, Young Mania Rating Scale (YMRS) for manic symptom severity, and the Beck Depression Inventory (BDI) for depressive symptoms\] 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LRFN5 and OLFM4 Levels in Schizoaffective Disorder: A Cross-Sectional Case-Control Study
- ClinicalTrials.gov ID
- NCT07447960
- Acronym / sponsor ID
- EMHDH-2026-SAD-LRFN5-OLFM4-01
- Conditions
- Schizoaffective Disorder
- Keywords
- Schizoaffective Disorder, LRFN5, OLFM4, Biomarkers, Neuroinflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 4 Mar 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
Key exclusion criteria (21 listed)
- For Healthy Control Group:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
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)
4 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)
Young Mania Rating Scale (YMRS)
Time frame: At hospital admission (baseline)
Beck Depression Inventory (BDI)
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 10 Sep 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, 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Schizoaffective 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 10 Sep 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 10 Sep 2026.