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Recruiting NCT07459257

Psychiatric Symptom Predictors in Methamphetamine-Induced Psychosis

Observational Methamphetamine Induced Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Methamphetamine Induced Psychosis. Basic parameters: 18 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of Factors Associated With Psychiatric Symptoms in Methamphetamine-Induced Psychotic Disorder: One-Year Longitudinal Study

Overview

This longitudinal observational study aimed to investigate environmental, familial, and individual factors associated with psychiatric symptom severity in participants diagnosed with methamphetamine-induced psychotic disorder (MP). Participants diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR) criteria was followed/will be followed prospectively for one year. Sociodemographic characteristics, treatment adherence, perceived social support, addiction-related clinical variables, insight levels, and psychotic symptoms was assessed/will be assessed monthly using standardized psychometric instruments. The study aimed to identify predictors associated with relapse-remission patterns and changes in psychiatric symptoms over a one-year follow-up period.

Detailed description

Methamphetamine is a potent central nervous system stimulant associated with strong addictive potential and widespread global misuse. Chronic exposure to methamphetamine leads to neurotoxic effects, dopaminergic dysregulation, and increased risk of psychosis.

Methamphetamine-induced psychotic disorder (MP) presents with symptoms such as auditory and visual hallucinations, persecutory delusions, suspiciousness, and, in some participants, negative symptoms including social withdrawal and reduced self-care. Although Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR) indicates that substance/drug-induced psychosis may resolve within one month, clinical observations suggest that psychotic symptoms may persist longer in some individuals.

Most previous studies investigating MP have used cross-sectional or retrospective designs. Longitudinal data describing the progression of psychiatric symptoms, relapse patterns, and factors influencing clinical outcomes remain limited.

The primary aim of the study was to identify environmental, familial, and individual factors influencing psychiatric symptom severity over time. Variables of interest include substance/drug use patterns, medication adherence, social support, insight levels, and addiction-related clinical features.

This study was designed as a one-year longitudinal follow-up study conducted at Elazığ Mental Health and Diseases Hospital. Male individuals diagnosed with MP according to DSM-5-TR criteria was enrolled/will be enrolled.

A sociodemographic and clinical information form was/will be administered to participants upon their initial admission. Psychiatric symptoms and addiction-related characteristics were/will be assessed using standardized psychometric scales. Participants were followed/will be followed prospectively for twelve months. Participants' contact information was/will be obtained (permission to contact them by phone was/will also be obtained), and the same psychometric scales and substance/drug use characteristics was/will be collected regularly once a month. A total of 12 interviews was/will be conducted with the same participant within 12 months. In each interview, particular attention was/will be paid to where they have lived in the last month and whether there have been any changes in their sociodemographic information. At the end of the monthly periods, participants who have not admitted to the hospital was/will be contacted by phone, and the fact that the interview was conducted by phone was/will be recorded (due to the possibility that the participants may have migrated to other cities or been imprisoned). Participants who cannot be reached despite all efforts (they was/will be called once a day for a week, and permission was/will be obtained for this) was/will have a note added to their "relevant month's" interview record indicating that the interview could not be conducted. At the end of each month, attempts was/will be made to contact all included participants again - regardless of whether they were reached the previous month or not - and the same procedures will continue each month. This means that even if a participant was only contacted upon admission and could not be contacted again, that participant was/will be included in the study. The aim here is to provide feedback on treatment and follow-up compliance in MP. The last participant was/will be included exactly one year after the start of the study, and 12 interviews was/will be conducted with this last participant over the course of a year. Participants included in the study with a diagnosis of MP during this one-year period will constitute the study sample.

The scales used/will be used in this study are as follows: Morisky Medication Adherence Scale, Multidimensional Scale of Perceived Social Support, Insight Assessment Scale, Addiction Profile Index Clinical-Practitioner Form, Positive and Negative Syndrome Scale, Global Assessment Scale.

After completion of the follow-up period, the data will be analyzed using SPSS statistical software and the results will be prepared for publication in scientific journals.

Primary outcome measures

  • Morisky Medication Adherence Scale (MMAS) [Time frame: To be obtained/will be obtained once a month for 12 months.]
  • Multidimensional Scale of Perceived Social Support (MSPSS) [Time frame: To be obtained/will be obtained once a month for 12 months.]
  • Insight Assessment Scale (IAS) [Time frame: To be obtained/will be obtained once a month for 12 months.]
  • Addiction Profile Index Clinical-Practitioner Form (API-C) [Time frame: To be obtained/will be obtained once a month for 12 months.]
  • Positive and Negative Syndrome Scale (PANSS) [Time frame: To be obtained/will be obtained once a month for 12 months.]
  • Global Assessment Scale (GAS) [Time frame: To be obtained/will be obtained once a month for 12 months.]

Eligibility criteria

  • Methamphetamine-Induced Psychotic Disorder (MP) Group:

\*Inclusion Criteria:

  • Diagnosis of MP according to DSM-5-TR
  • Medication-free for at least one month prior to admission
  • Age ≥ 18 years and <65 years
  • Provided informed consent
  • Methamphetamine-Induced Psychotic Disorder (MP) Group:
  • Exclusion Criteria:
  • Hypertension
  • Diabetes mellitus
  • Chronic kidney disease
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Cardiac illness
  • Severe neurological disorders
  • Immunological or systemic illness
  • Primary psychiatric disorders other than MP
  • Alcohol use disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Elazığ Mental Health and Diseases Hospital — Elâzığ

Publications

  • Ghaffari-Nejad A, Ziaadini H, Saffari-Zadeha S, Kheradmand A, Pouya F. A study of the phenomenology of psychosis induced by methamphetamine: a preliminary research. Addict Health. 2014 Summer-Autumn;6(3-4):105-11. PMID 25984277
  • McKetin R, Baker AL, Dawe S, Voce A, Lubman DI. Differences in the symptom profile of methamphetamine-related psychosis and primary psychotic disorders. Psychiatry Res. 2017 May;251:349-354. doi: 10.1016/j.psychres.2017.02.028. Epub 2017 Feb 13. PMID 28282630
  • Wearne TA, Cornish JL. A Comparison of Methamphetamine-Induced Psychosis and Schizophrenia: A Review of Positive, Negative, and Cognitive Symptomatology. Front Psychiatry. 2018 Oct 10;9:491. doi: 10.3389/fpsyt.2018.00491. eCollection 2018. PMID 30364176
  • Glasner-Edwards S, Mooney LJ. Methamphetamine psychosis: epidemiology and management. CNS Drugs. 2014 Dec;28(12):1115-26. doi: 10.1007/s40263-014-0209-8. PMID 25373627
  • Courtney KE, Ray LA. Methamphetamine: an update on epidemiology, pharmacology, clinical phenomenology, and treatment literature. Drug Alcohol Depend. 2014 Oct 1;143:11-21. doi: 10.1016/j.drugalcdep.2014.08.003. Epub 2014 Aug 17. PMID 25176528

Identifiers

NCT: NCT07459257 · EMHDH-2025/26-METH-PSYCHS-LONG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗