Not Yet RecruitingNot Applicable

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.

200 participantsStarted 2025-10-24

Plain-language 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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

severity of symptoms of psychosis at time of presentation

Timeframe: from enrollment to 3 Months

Trial details

NCT IDNCT07184710

SponsorSohag University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-25

Contact for this trial

ali alaaeldeen kenawy, M.B.B.Ch

+20 ali.alaaeldeen@med.sohag.edu.eg

View on ClinicalTrials.gov More Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis trials