An observational study in Methamphetamine Use Disorder and Methamphetamine Induced Psychosis, sponsored by Elazığ Mental Health and Diseases Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Elazığ Mental Health and Diseases Hospital · Observational
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.
Methamphetamine is a potent central nervous system stimulant associated with addiction, neurotoxicity, and increased cardiovascular morbidity and mortality. Chronic methamphetamine exposure leads to sympathetic nervous system activation, elevated catecholamine levels, hypertension, myocardial ischemia, arrhythmias, cardiomyopathy, and increased risk of sudden cardiac death.
Cardiovascular complications in methamphetamine users may result from repeated catecholamine surges, endothelial damage, coronary vasospasm, thrombus formation, myocardial fibrosis, and electrical instability. Electrocardiogram (ECG) abnormalities such as prolonged QTc interval, QT dispersion (QTd), Tp-e interval prolongation, Tp-e/QTc ratio increase, ST depression, and P-wave dispersion may reflect arrhythmogenic risk.
Previous studies have demonstrated ECG abnormalities in subjects with Methamphetamine Use Disorder (MUD). However, electrocardiographic findings in Methamphetamine-Induced Psychotic Disorder (MP) have not been prospectively investigated. Evidence suggests that subjects with MP may have higher long-term cardiovascular risk compared to subjects with MUD.
This study is designed as a prospective cohort study conducted in the closed inpatient psychiatric ward of Elazığ Mental Health and Diseases Hospital. Subjects hospitalized with a diagnosis of MUD or MP according to DSM-5-TR criteria will be included. Only subjects with positive urine toxicology for methamphetamine at admission will be enrolled.
At hospital admission and prior to discharge (remission period), the following routine clinical data will be recorded: ECG, Complete blood count. 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.
ECGs will be interpreted by a cardiology specialist, and pathological findings will be documented. Psychiatric symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS). Sociodemographic and substance use characteristics will also be recorded.
Admission ECG findings will be compared with remission ECG findings within groups, and ECG parameters will be compared between MUD and MP groups to determine whether psychosis is associated with increased cardiac risk.
Statistical analyses will be performed using SPSS version 26. Appropriate parametric or non-parametric tests will be used depending on data distribution. Independent and dependent sample analyses will be conducted. Correlation, regression, and ROC analyses will be performed where appropriate. Statistical significance will be defined as p\<0.05. When the alpha value is accepted as 0.05, the beta value as 0.2 and the power as 80%, it was concluded that there should be at least 3 participants in each group. In this study, we plan to form each group with 80 participants.
Elazığ Mental Health and Diseases Hospital is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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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.
For Methamphetamine Use Disorder (MUD) Group:
*Inclusion Criteria:
For Methamphetamine Use Disorder (MUD) Group:
*Exclusion Criteria:
For Methamphetamine-Induced Psychotic Disorder (MP) Group:
*Inclusion Criteria:
For Methamphetamine-Induced Psychotic Disorder (MP) Group:
*Exclusion Criteria:
For Healthy Control Group:
*Inclusion Criteria:
For Healthy Control Group:
*Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants (18-65 years) diagnosed with Methamphetamine Use Disorder according to DSM-5-TR criteria. No intervention was/will be assigned by the study protocol. Participants were/will be evaluated at baseline and after 6 weeks of routine clinical treatment. Electrocardiogram (ECG) and complete blood count were/will be obtained from participants at baseline and after six weeks of follow-up. No psychometric scales were/will be administered to this group. Sociodemographic and clinical data were/will be recorded for all participants.
Adult participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to DSM-5-TR criteria. No intervention was/will be assigned by the study protocol. Participants were/will be evaluated at baseline and after 6 weeks of routine clinical treatment. Electrocardiogram (ECG) and complete blood count were/will be obtained from participants at baseline and after six weeks of follow-up. Psychotic symptom severity was/will be assessed using the Positive and Negative Syndrome Scale (PANSS). Insight Assessment Scale (IAS) was/will be used to measure the insight level. Sociodemographic and clinical data were/will be recorded for all participants.
Healthy control (HC) adult participants (18-65 years) without any current or past psychiatric disorder. No intervention was administered as part of the research protocol. Participants underwent a baseline clinical evaluation and provided a single blood sample for measurement of complete blood count. Sociodemographic and clinical data were recorded for all participants. As of December 15, 2025, the recruitment of HC participants has been completed.
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)
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)
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 hospitalization
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 hospitalization
Plan to share: Yes — Deidentified individual participant data (IPD) underlying the results reported in this study [including demographic variables, electrocardiogram (ECG), complete blood count parameters, and Positive and Negative Syndrome Scale (PANSS) and Insight Assessment Scale (IAS)] 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.
Supporting information: Study protocol
Time frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
Access criteria: 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.
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Elazığ Mental Health and Diseases Hospital