Could α-N-acetylgalactosaminidase Levels Be Associated With the Presence of Psychotic Symptoms in Methamphetamine Use Disorder? A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- α-N-acetylgalactosaminidase
研究概览
简要总结
This cross-sectional observational cohort study examined serum α-N-acetylgalactosaminidase levels in methamphetamine use disorder (MUD), methamphetamine-induced psychotic disorder (MP), and healthy control (HC) groups. The study aimed to determine whether decreased α-N-acetylgalactosaminidase levels are associated with psychotic symptoms in methamphetamine users.
详细描述
Methamphetamine use disorder (MUD) is frequently complicated by the emergence of psychotic symptoms, which may range from transient intoxication-related psychosis to persistent methamphetamine-induced psychotic disorder (MP). Although clinical and biological differences between MUD and MP are increasingly being investigated, the role of α-N-acetylgalactosaminidase, a lysosomal enzyme involved in glycoconjugate metabolism and immune regulation, has not been previously examined in this population.
This cross-sectional observational study aimed to compare serum α-N-acetylgalactosaminidase levels among three groups: patients with methamphetamine use disorder (MUD), patients with methamphetamine-induced psychotic disorder (MP), and healthy control (HC) subjects. A secondary objective was to evaluate associations between α-N-acetylgalactosaminidase levels, psychotic symptom severity, and systemic inflammation, and to assess its potential predictive value for MP diagnosis.
Participants were consecutive inpatients diagnosed with MUD or MP according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). All patients were admitted to Elazığ Mental Health and Diseases Hospital between May 1, 2025 and August 31, 2025. The healthy control group consisted of individuals without current or past psychiatric disorders or significant medical illnesses. Adult male participants aged 18-65 years were included.
Venous blood samples were collected at hospital admission prior to initiation of treatment. Samples were centrifuged within 30 minutes and serum was stored at -80°C until analysis. Serum α-N-acetylgalactosaminidase levels were measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Routine biochemical analyses and urine toxicology screening were also performed. The Aggregate Index of Systemic Inflammation (AISI) was calculated as (neutrophils × monocytes × platelets) / lymphocytes.
Psychotic symptom severity in the MP group was assessed using the Positive and Negative Syndrome Scale (PANSS). Sociodemographic variables and clinical characteristics, including self-mutilation history, drug use onset age, duration of methamphetamine use, and smoking status, were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •For Methamphetamine Use Disorder (MUD) Group:
- •*Inclusion Criteria:
- •Diagnosis of MUD according to DSM-5-TR
- •Medication-free for at least one month prior to admission
- •Age ≥ 18 years and <65 years
- •Provided informed consent
- •For Methamphetamine Use Disorder (MUD) 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 MUD
- •Alcohol use disorder
- •For 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
- •For 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
- •For Healthy Control Group:
- •*Inclusion Criteria:
- •No psychiatric diagnosis
- •No systemic or immunological illness
- •Medication-free for at least one month
- •Age ≥ 18 years and < 65 years
- •Provided informed consent
- •For Healthy Control 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 schizophrenia
- •Alcohol/drug/substance use
研究组 & 干预措施
Methamphetamine Use Disorder
Adult participants (18-65 years) diagnosed with Methamphetamine Use Disorder according to DSM-5-TR criteria. Participants were evaluated at hospital admission (baseline). No intervention was assigned by the study protocol. Blood samples were collected for measurement of serum α-N-acetylgalactosaminidase levels and complete blood count parameters. No psychometric scales were administered to this group. Sociodemographic and clinical data were recorded for all participants.
Methamphetamine-Induced Psychotic Disorder
Adult participants (18-65 years) diagnosed with Methamphetamine-Induced Psychotic Disorder according to DSM-5-TR criteria. Participants were evaluated at hospital admission (baseline). No intervention was assigned by the study protocol. Blood samples were collected for measurement of serum α-N-acetylgalactosaminidase levels and complete blood count parameters. Psychotic symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS). Sociodemographic and clinical data were recorded for all participants.
Healthy Control
Healthy control 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 serum α-N-acetylgalactosaminidase levels and complete blood count inflammatory markers. Sociodemographic and clinical data were recorded for all participants.
结局指标
主要结局
α-N-acetylgalactosaminidase
时间窗: At hospital admission (baseline)
Serum α-N-acetylgalactosaminidase levels measured by ELISA (ng/mL).
次要结局
- Aggregate Index of Systemic Inflammation (AISI)(At hospital admission (baseline))
- Positive and Negative Syndrome Scale (PANSS) Score(At hospital admission (baseline))
研究者
Mehmet Hamdi ÖRÜM
Associate Professor Mehmet Hamdi Örüm, MD, Psychiatrist
Elazığ Mental Health and Diseases Hospital