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NCT Number: NCT07184710

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.

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

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Key information

Conditions

Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis Mental Disorders Methamphetamine Induced Psychosis Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

severity of symptoms of psychosis at time of presentation

Time frame: 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

Secondary outcomes

improvement after treatment and/or hospitalization

Time frame: after 3 months of first visit.

using positive and negative syndrome scale of schizophrenia PANSS Total score minimum = 30, maximum = 210 to compare response to treatment and prognosis of 2 groups

Study contacts

Contact information is provided by the study sponsor or research team.

ali alaaeldeen kenawy, M.B.B.Ch

CONTACT

[email protected]

+20 ext. 01127311264

osama eltaher mahmoud, Ph.D

CONTACT

+20 ext. 0100066135

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Comparative Study Between Methamphetamine Induced Psychosis and Schizophrenia in Sohag Governorate

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 22, 2025
Registry last updated: Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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