NCT07184710

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:

  • the need of hospitalization and its duration
  • time of recovery
  • job dysfunction duration

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Oct 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Oct 2025Aug 2026

First Submitted

Initial submission to the registry

September 2, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 2, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

psychosisschizophreniaMETHcomparative

Outcome Measures

Primary Outcomes (1)

  • 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

    from enrollment to 3 Months

Secondary Outcomes (1)

  • improvement after treatment and/or hospitalization

    after 3 months of first visit.

Study Arms (2)

schizophrenia

METH induced psychosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample thus comprised all available patients with methamphetamine-related psychosis or schizophrenia attending the clinic during the study period.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Taher abdelrhim Sayed, Prof.

    faculy of medicine_ sohag university

    STUDY CHAIR
  • osama abdelraouf Morad, Ph.D

    faculy of medicine_ sohag university

    STUDY CHAIR
  • osama eltaher mahmoud, Ph.D

    faculy of medicine_ sohag university

    STUDY CHAIR

Central Study Contacts

ali alaaeldeen kenawy, M.B.B.Ch

CONTACT

osama eltaher mahmoud, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.B.B.Ch resident in neurology and psychological medicine department sohag university

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 22, 2025

Study Start

October 24, 2025

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

August 25, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09