LRFN5 and OLFM4 in Schizoaffective Disorder
ConditionSchizoaffective Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorElazığ Mental Health and Diseases Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Alcohol/drug/substance use
Medication-free for at least one month
Age ≥ 18 years and < 65 years
Provided informed consent
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Schizoaffective Disorder (SAD)
Group B: Healthy Control (HC)
Trial outcomes
Primary outcomes
1
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)
Time frame
At hospital admission (baseline)2
Olfactomedin-4 (OLFM4)
Serum olfactomedin-4 (OLFM4) levels measured by ELISA (pg/ml)
Time frame
At hospital admission (baseline)Secondary outcomes
1
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.
Time frame
At hospital admission (baseline)2
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.
Time frame
At hospital admission (baseline)3
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.
Time frame
At hospital admission (baseline)4
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.
Time frame
At hospital admission (baseline)Sponsors and contacts
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Source ClinicalTrials.gov
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