Investigation of Factors Associated With Psychiatric Symptoms in Methamphetamine-Induced Psychotic Disorder: One-Year Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Morisky Medication Adherence Scale (MMAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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:
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Morisky Medication Adherence Scale (MMAS)
时间窗: To be obtained/will be obtained once a month for 12 months.
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.
Multidimensional Scale of Perceived Social Support (MSPSS)
时间窗: To be obtained/will be obtained once a month for 12 months.
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.
Insight Assessment Scale (IAS)
时间窗: To be obtained/will be obtained once a month for 12 months.
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.
Addiction Profile Index Clinical-Practitioner Form (API-C)
时间窗: To be obtained/will be obtained once a month for 12 months.
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.
Positive and Negative Syndrome Scale (PANSS)
时间窗: To be obtained/will be obtained once a month for 12 months.
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.
Global Assessment Scale (GAS)
时间窗: To be obtained/will be obtained once a month for 12 months.
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.
次要结局
未报告次要终点
研究者
Mehmet Hamdi ÖRÜM
Associate Professor, MD, Psychiatrist
Elazığ Mental Health and Diseases Hospital