ECG Findings in Methamphetamine Use
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-65
SponsorElazığ Mental Health and Diseases Hospital
About this trial
This prospective cohort study aims to examine and compare electrocardiogram (ECG) parameters in subjects diagnosed with Methamphetamine Use Disorder (MUD) and Methamphetamine-Induced Psychotic Disorder (MP) during inpatient psychiatric treatment. ECG findings at hospital admission and during remission prior to discharge will be evaluated and compared between groups. The study also aims to determine whether methamphetamine-induced psychosis is associated with greater ECG abnormalities and increased cardiac risk compared to methamphetamine use without psychosis.
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 methamphetamine-induced psychotic disorder (MP) group included/will include consecutive inpatients diagnosed with 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
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 3 trial groupsGroup A: Methamphetamine Use Disorder (MUD)
Group B: Methamphetamine-Induced Psychotic Disorder (MP)
Group C: Healthy Control (HC)
Trial outcomes
Primary outcomes
1
Electrocardiogram (ECG)
The process of recording these electrical currents generated in the heart on paper is called an electrocardiogram (ECG). An ECG consists of waves. These waves are composed of P, Q, R, S, T waves and various intervals (such as the PR interval and QT interval). The P wave occurs during the contraction of the atria, and the QRS wave occurs during the contraction of the ventricles. ECG parameters to be evaluated include: QT interval, QTc interval, QRS duration, Tp-e interval, Tp-e/QTc ratio, ST depression, P-wave dispersion, QT dispersion, fragmented QRS.
Time frame
At baseline and at 6 weeks of hospitalization (for healhty control group only at baseline)Secondary outcomes
1
Complete Blood Count (CBC)
A complete blood count (CBC) is a group of blood tests that measure the number and size of the different cells in blood. A CBC measures red blood cells, white blood cells, platelets, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, mean corpuscular hemoglobin, lymphocyte, neutrophil, monocyte, eosinophil, basophil, red blood cell distribution width.
Time frame
At baseline and at 6 weeks of hospitalization (for healhty control group only at 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 baseline and at 6 weeks of hospitalization3
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. This scale was only administered to the methamphetamine-induced psychotic disorder group.
Time frame
At baseline and at 6 weeks of hospitalizationSponsors and contacts
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Source ClinicalTrials.gov