Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:39 AM
Study NCT ID:
NCT07459257
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric Symptom Predictors in Methamphetamine-Induced Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morisky Medication Adherence Scale (MMAS)', 'timeFrame': 'To be obtained/will be obtained once a month for 12 months.', 'description': '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.'}, {'measure': 'Multidimensional Scale of Perceived Social Support (MSPSS)', 'timeFrame': 'To be obtained/will be obtained once a month for 12 months.', 'description': '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.'}, {'measure': 'Insight Assessment Scale (IAS)', 'timeFrame': 'To be obtained/will be obtained once a month for 12 months.', 'description': '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.'}, {'measure': 'Addiction Profile Index Clinical-Practitioner Form (API-C)', 'timeFrame': 'To be obtained/will be obtained once a month for 12 months.', 'description': "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."}, {'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'To be obtained/will be obtained once a month for 12 months.', 'description': "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."}, {'measure': 'Global Assessment Scale (GAS)', 'timeFrame': 'To be obtained/will be obtained once a month for 12 months.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methamphetamine', 'Methamphetamine-Induced Psychosis', 'Psychiatric Symptoms', 'Methamphetamine-Induced Psychotic Disorder', 'Longitudinal Study'], 'conditions': ['Methamphetamine Induced Psychosis']}, 'referencesModule': {'references': [{'pmid': '25984277', 'type': 'BACKGROUND', 'citation': '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': '28282630', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Wearne TA,Cornish JL'}, {'type': 'BACKGROUND', 'citation': 'Glasner-Edwards S,Mooney LJ'}, {'type': 'BACKGROUND', 'citation': 'Courtney KE,Ray LA'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe study aimed to identify predictors associated with relapse-remission patterns and changes in psychiatric symptoms over a one-year follow-up period.', 'detailedDescription': '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.\n\nMethamphetamine-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.\n\nMost 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.\n\nThe 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.\n\nThis 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.\n\nA 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.\n\nThe 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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).\n\nMP 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.', 'healthyVolunteers': True, 'eligibilityCriteria': '* Methamphetamine-Induced Psychotic Disorder (MP) Group:\n\n \\*Inclusion Criteria:\n * Diagnosis of MP according to DSM-5-TR\n * Medication-free for at least one month prior to admission\n * Age ≥ 18 years and \\<65 years\n * Provided informed consent\n* Methamphetamine-Induced Psychotic Disorder (MP) Group:\n\n * Exclusion Criteria:\n\n * Hypertension\n * Diabetes mellitus\n * Chronic kidney disease\n * Rheumatoid arthritis\n * Systemic lupus erythematosus\n * Cardiac illness\n * Severe neurological disorders\n * Immunological or systemic illness\n * Primary psychiatric disorders other than MP\n * Alcohol use disorder'}, 'identificationModule': {'nctId': 'NCT07459257', 'briefTitle': 'Psychiatric Symptom Predictors in Methamphetamine-Induced Psychosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Elazığ Mental Health and Diseases Hospital'}, 'officialTitle': 'Investigation of Factors Associated With Psychiatric Symptoms in Methamphetamine-Induced Psychotic Disorder: One-Year Longitudinal Study', 'orgStudyIdInfo': {'id': 'EMHDH-2025/26-METH-PSYCHS-LONG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Methamphetamine-Induced Psychotic Disorder (MP)', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23200', 'city': 'Elâzığ', 'state': 'Elâzığ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist', 'role': 'CONTACT', 'email': 'mhorum@hotmail.com', 'phone': '+905382207558'}], 'facility': 'Elazığ Mental Health and Diseases Hospital', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'centralContacts': [{'name': 'Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist', 'role': 'CONTACT', 'email': 'mhorum@hotmail.com', 'phone': '+905382207558'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning 6 months after publication and will remain available for 5 years.', 'ipdSharing': 'YES', 'description': 'Deidentified individual participant data (IPD) underlying the results reported in this study \\[including sociodemographic variables, 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\\] will be made available to qualified researchers upon reasonable request for academic purposes.\n\nData 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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elazığ Mental Health and Diseases Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD, Psychiatrist', 'investigatorFullName': 'Mehmet Hamdi ÖRÜM', 'investigatorAffiliation': 'Elazığ Mental Health and Diseases Hospital'}}}}