Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced PsychosisNCT07184710
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.
An observational study of Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis and SCHIZOPHRENIA, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis, SCHIZOPHRENIA, Methamphetamine Induced Psychosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2025to 25 Aug 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The sample thus comprised all available patients with methamphetamine-related psychosis or schizophrenia attending the clinic during the study period.
Who may be able to join
- 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.
Who cannot join
- included presence of primary neurological disorders (e.g., epilepsy, dementia), significant medical illness affecting cognition, or inability to participate in interviews.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
osama eltaher mahmoud, Ph.D contact
About this study
Official title: Comparative Study Between Methamphetamine Induced Psychosis and Schizophrenia in Sohag Governorate
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:
Read more
- 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.
- 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.
- 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.
- 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:
- Clinical profile-risk factors-of schizophrenia vs methamphetamine induced psychosis in sohag governorate
- Compare between response to treatment
- the need of hospitalization and its duration
- time of recovery
- job dysfunction duration
- Conditions
- Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis, SCHIZOPHRENIA, Methamphetamine Induced Psychosis
- Keywords
- psychosis, schizophrenia, METH, comparative
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | Not described | |
| METH induced psychosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of symptoms of psychosis at time of presentation
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
Measured: from enrollment to 3 Months
Secondary outcomes (1)
improvement after treatment and/or hospitalization
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
Measured: after 3 months of first visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start24 Oct 2025 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aly Alaa-eldeen Kenawy, Sohag University
- Investigators
- Taher abdelrhim Sayed, Prof., Study chair, faculy of medicine_ sohag universityosama abdelraouf Morad, Ph.D, Study chair, faculy of medicine_ sohag universityosama eltaher mahmoud, Ph.D, Study chair, faculy of medicine_ sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184710
- Sponsor's protocol ID
- soh-Med--25-8-3MS
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Methamphetamine Induced Psychosis and Schizophrenia in Sohag Governorate
- ClinicalTrials.gov ID
- NCT07184710
- Acronym / sponsor ID
- soh-Med--25-8-3MS
- Conditions
- Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis, SCHIZOPHRENIA, Methamphetamine Induced Psychosis
- Keywords
- psychosis, schizophrenia, METH, comparative
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 24 Oct 2025 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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:
- Clinical profile-risk factors-of schizophrenia vs methamphetamine induced psychosis in sohag governorate
- Compare between response to treatment
- the need of hospitalization and its duration
- time of recovery
- job dysfunction duration
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | – |
| METH induced psychosis | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The sample thus comprised all available patients with methamphetamine-related psychosis or schizophrenia attending the clinic during the study period.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- included presence of primary neurological disorders (e.g., epilepsy, dementia), significant medical illness affecting cognition, or inability to participate in interviews.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
improvement after treatment and/or hospitalization
Time frame: after 3 months of first visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
osama eltaher mahmoud, Ph.D contact
Taher abdelrhim Sayed, Prof. study chair
faculy of medicine_ sohag university
osama abdelraouf Morad, Ph.D study chair
faculy of medicine_ sohag university
osama eltaher mahmoud, Ph.D study chair
faculy of medicine_ sohag university
Questions about this trial
What is this clinical trial studying?
An observational study of Comparing Clinical Profile and Prognosis of Schizophrenia Versus Methamphetamine Induced Psychosis and SCHIZOPHRENIA, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ali alaaeldeen kenawy, M.B.B.Ch (+20 ext. 01127311264, ali.alaaeldeen@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of symptoms of psychosis at time of presentation (time frame: from enrollment to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.