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 Two Groups a Case of Schizophrenia or a Case of Methamphetamine Induced Psychosis

Not yet recruiting

• Conditions: This is Observational Study; Comparing Between METH Induced Psychosis and Schizophrenia; Comparing Aspects Includes Clinical Profile _ Risk factors_ Response to Treatment

• Registration Number: NCT07184710
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-14
• Last Update Submitted: 2025-09-14
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-24
• Primary Completion: 2026-08-25
• Study Completion: 2026-08-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
positive and negative syndrome scale	from enrollment to 3 Months	clinical tool to assess severity of symptoms of schizophrenia or psychosis

Secondary Outcome Measures

Name	Time	Method
compare response to treatment	from enrollment to 3 months	using positive and negative syndrome scale after follow up visit within 3 months