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.

NCT ID: NCT07184710

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-24

Study Completion Date

2026-08-25

Brief Summary

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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

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Conditions

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Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis SCHIZOPHRENIA Methamphetamine Induced Psychosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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schizophrenia

No interventions assigned to this group

METH induced psychosis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Aly Alaa-eldeen Kenawy

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taher abdelrhim Sayed, Prof.

Role: STUDY_CHAIR

faculy of medicine_ sohag university

osama abdelraouf Morad, Ph.D

Role: STUDY_CHAIR

faculy of medicine_ sohag university

osama eltaher mahmoud, Ph.D

Role: STUDY_CHAIR

faculy of medicine_ sohag university

Central Contacts

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ali alaaeldeen kenawy, M.B.B.Ch

Role: CONTACT

+20 ext. 01127311264

osama eltaher mahmoud, Ph.D

Role: CONTACT

+20 ext. 0100066135

Other Identifiers

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soh-Med--25-8-3MS

Identifier Type: -

Identifier Source: org_study_id

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