LRFN5 and OLFM4 in Methamphetamine-Induced Psychosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-49
SponsorElazığ Mental Health and Diseases Hospital
About this trial
This cross-sectional observational case-control study aimed to examined serum levels of leucine-rich repeat and fibronectin type III domain-containing protein 5 (LRFN5) and olfactomedin-4 (OLFM4) levels in methamphetamine use disorder (MUD), methamphetamine-induced psychotic disorder (MP), and healthy control (HC) groups. The study also aimed to assessed systemic inflammation using the Aggregate Index of Systemic Inflammation (AISI) and examined associations between biomarkers and clinical symptom severity, including Insight Assessment Scale (IAS) and Positive and Negative Syndrome Scale (PANSS) scores.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of MUD according to DSM-5-TR
Medication-free for at least one month prior to admission
Age ≥ 18 years and <65 years
Provided informed consent
Disqualifiers
Diabetes mellitus
Chronic kidney disease
Rheumatoid arthritis
Systemic lupus erythematosus
Trial population
The study population consisted/will be consisted of adult male inpatients aged 18-65 years who were admitted to Elazığ Mental Health and Diseases Hospital. The MP group included/will include consecutive inpatients diagnosed with methamphetamine-induced psychotic disorder (MP) and the methamphetamine use disorder (MUD) group included/will include consecutive inpatients diagnosed with MUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Both patient groups consisted of active methamphetamine users and were hospitalized for clinical management at the time of assessment. Urine toxicology screening was performed at admission to confirm substance use status. The Healthy Control (HC) group consisted of adult male individuals without current or past psychiatric disorders and without substance use disorders, matched to patient groups in terms of age and body mass index. HCs had no significant medical illnesses.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 3 trial groupsGroup A: Methamphetamine Use Disorder
Group B: Methamphetamine-Induced Psychotic Disorder
Group C: Healthy Control
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. This scale was only administered to the methamphetamine-induced psychotic disorder group.
Time frame
At hospital admission (baseline)3
Insight Assessment Scale (IAS)
It was reported that insight cannot be evaluated as either present or absent, and it was defined it as a three-way process consisting of compliance with treatment, awareness of the illness, and accurate recognition of psychotic experiences. Based on these components, Insight Assessment Scale (IAS) was developed as a clinician-administered scale that quantitatively assesses insight for individuals with psychosis. IAS is an 8-question, clinician-administered, semi-structured scale. "Treatment acceptance"(1a), " treatmentrequest" (1b), "knowledge of illness" (2a), "knowledge of mental illness" (2b), "explanation of illness" (2c), "In addition to the 7 subscales titled "believing in the truth of the delusion" (3a), "explaining their experiences" (3b), there is a subscale titled "reaction to disbelief". The highest total score with this question is 18. A high score indicates a high level of insight.
Time frame
At hospital admission (baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov