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临床试验/NCT07184710
NCT07184710尚未招募不适用

Comparative Study Between Methamphetamine Induced Psychosis and Schizophrenia in Sohag Governorate

Sohag University0 个研究点目标入组 200 人开始时间: 2025年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
severity of symptoms of psychosis at time of presentation

研究概览

简要总结

This hospital-based observational study employed prospective follow up study will be conducted in sohag university hospital clinics aiming to ensure cases presented with psychosis in two phases to differentiate into 2 groups (a case of schizophrenia or a case of METH induced psychosis)

Phases-1 includes:

  1. Screening and Consent: All consecutive patients meeting initial criteria for psychosis were informed about the study. After explaining the procedures, written informed consent was obtained.
  2. Diagnostic Interview: Each participant underwent a SCID-5 interview to confirm DSM-5 diagnoses. The SCID modules relevant to psychotic disorders were used (including the psychotic and substance-use modules). Information from patient self-report and available medical records was incorporated into the diagnostic assessment.
  3. Symptom Rating: Following diagnosis, a trained clinician conducted the PANSS interview. This involved structured questions about symptoms over the past week, supplemented by clinical observation. Each PANSS item was scored on a 1-7 scale according to established guidelines. The positive- and negative-symptom subscale scores were recorded for analysis.
  4. Clinical Data: A semi-structured form was used to record demographic data, psychiatric history (age at onset, duration of illness), medication history, and details of methamphetamine use (duration, frequency, last use and drug screening). Data were entered into a secure study database.

Phase 2 includes:

Follow up visit after 3 months to obtain :

Positive and Negative Syndrome Scale (PANSS) Drug screening Time of recovery, response to treatment, relapse , job dysfunction duration.

Aim of the study:

The study aims to compare between:

  1. Clinical profile-risk factors-of schizophrenia vs methamphetamine induced psychosis in sohag governorate
  2. Compare between response to treatment
  • the need of hospitalization and its duration
  • time of recovery
  • job dysfunction duration

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients presenting to the outpatient department with active psychotic symptoms were screened for inclusion. Eligible participants were adults (age ≥18 ≤60) meeting DSM-5 criteria for either methamphetamine-induced psychotic disorder or schizophrenia.

排除标准

  • included presence of primary neurological disorders (e.g., epilepsy, dementia), significant medical illness affecting cognition, or inability to participate in interviews.

结局指标

主要结局

severity of symptoms of psychosis at time of presentation

时间窗: from enrollment to 3 Months

using positive and negative syndrome scale of schizophrenia Positive scale 7 Items, (minimum score = 7, maximum score = 49) includes : Delusions Conceptual disorganization Hallucinations Excitement Grandiosity Suspiciousness/persecution Hostility Negative scale 7 Items, (minimum score = 7, maximum score = 49) includes : Blunted affect Emotional withdrawal Poor rapport Passive/apathetic social withdrawal Difficulty in abstract thinking Lack of spontaneity and flow of conversation Stereotyped thinking General Psychopathology scale 16 Items, (minimum score = 16, maximum score = 112) includes : Somatic concern Anxiety Guilt feelings Tension Mannerisms and posturing Depression Motor retardation Uncooperativeness Unusual thought content Disorientation Poor attention Lack of judgment and insight Disturbance of volition Poor impulse control Preoccupation Active social avoidance PANSS Total score minimum = 30, maximum = 210

次要结局

  • improvement after treatment and/or hospitalization(after 3 months of first visit.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aly Alaa-eldeen Kenawy

M.B.B.Ch_resident in neurology and psychological medicine department_sohag university

Sohag University

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