Psychiatric Symptom Predictors in Methamphetamine-Induced Psychosis

NCT07459257 | Recruiting DMC

• 1 other identifier: EMHDH-2025/26-METH-PSYCHS-LONG
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Induced Psychosis

Keywords

Methamphetamine; Methamphetamine-Induced Psychosis; Psychiatric Symptoms; Methamphetamine-Induced Psychotic Disorder; Longitudinal Study

Outcome Measures

Primary Outcomes (6)

• Morisky Medication Adherence Scale (MMAS)

  The scale consists of four two-option (yes/no) closed-ended questions. In Turkey, a validity and reliability study was conducted to measure adherence to antipsychotic treatment. A "yes" answer indicates poor adherence to medical treatment. A "no" answer indicates good adherence to medical treatment. A higher number of "yes" answers indicates poor adherence to medical treatment.

  To be obtained/will be obtained once a month for 12 months.

• Multidimensional Scale of Perceived Social Support (MSPSS)

  The scale consists of 12 items. It is a 7-point Likert-type scale ranging from "Absolutely not 1, 2, 3, 4, 5, 6, 7 Absolutely yes". A higher score indicates higher perceived social support.

  To be obtained/will be obtained once a month for 12 months.

• 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.

  To be obtained/will be obtained once a month for 12 months.

• Addiction Profile Index Clinical-Practitioner Form (API-C)

  API was developed to measure the factors related to addiction. It is a measure of 37 questions and 5 subscales. Subscales measure the substance use characteristics, dependency diagnostic criteria, the effect of substance use on the individual's life, the craving for substance use and the motivation to quit substance use. API-C includes the assessment of the six areas related to the addiction apart from areas where the API measures directly. Two of these six areas measure mental status, while others measure some personal characteristics of addiction. These areas are; depression, anxiety, anger control failure, lack of safe behavior, excitement seeking behavior and impulsiveness. In addition to the 37 questions in the API, there are 21 more questions in the API-C. Self-notification and enforcement forms are available. In our study, API-C Practitioner Form was used.

  To be obtained/will be obtained once a month for 12 months.

• Positive and Negative Syndrome Scale (PANSS)

  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.

  To be obtained/will be obtained once a month for 12 months.

• Global Assessment Scale (GAS)

  It is a rating scale that is administered quickly and covers all aspects of changes in psychopathology (psychological, social, and occupational functioning). Developed in 1976, it is scored from 0 to 100. A lower score is associated with a lower level of functioning.

  To be obtained/will be obtained once a month for 12 months.

Study Arms (1)

Methamphetamine-Induced Psychotic Disorder (MP)

Adult male participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5-TR) criteria. No intervention was/will be assigned by the study protocol. At baseline, participants completed/will complete a sociodemographic and clinical information form. Psychiatric symptoms and addiction-related characteristics will be assessed using standardized psychometric scales. Participants were followed/will then be followed prospectively for twelve months. Participants will be contacted monthly to complete the same clinical assessments. 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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted/will be consisted of adult male participants 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 participants diagnosed with MP according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). MP group consisted/will 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/drug use status.

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Elazığ Mental Health and Diseases Hospital

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• Wearne TA,Cornish JL

  BACKGROUND

• Glasner-Edwards S,Mooney LJ

  BACKGROUND

• Courtney KE,Ray LA

  BACKGROUND

Central Study Contacts

Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist

CONTACT

+905382207558; mhorum@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, Psychiatrist

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: February 3, 2025
• Primary Completion: July 28, 2025
• Study Completion (Estimated): August 17, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

TU (1)