This Hospital-based Observational Study Employed a Study Will be Conducted in Sohag University Hospital Clinics Aiming to Ensure Cases Presented With Psychosis in Two Phases to Differentiate Into Two Groups a Case of Schizophrenia or a Case of Methamphetamine Induced Psychosis.

Официальное название

Comparative Study Between Methamphetamine Induced Psychosis and Schizophrenia in Sohag Governorate

Обзор

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

Первичные конечные точки

• severity of symptoms of psychosis at time of presentation [Срок оценки: from enrollment to 3 Months]

Вторичные конечные точки (1)

• improvement after treatment and/or hospitalization [Срок оценки: after 3 months of first visit.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07184710 · soh-Med--25-8-3MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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