Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study.

NCT05939765 | Withdrawn

• 1 other identifier: AiW-TlG
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Considering the vulnerability of patients with schizophrenia in forensic treatment, we have designed a prospective-observational trial. The purpose of our study, notably its focus on selecting the appropriate medication, developing clinical profiles, and determining the grounds of clinical judgment, is relevant for treating patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Pharmacologic Treatment; Forensic Treatment; Antipsychotics; Violent Behavior

Outcome Measures

Primary Outcomes (1)

• Psychopathology

  The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview designed to meas-ure the severity of psychopathology in patients with a psychotic disorder. The scale ranges from 30 to 210; higher scores mean greater psychopathology. Change from baseline in psychopathology on the PANSS.

  4 weeks

Secondary Outcomes (2)

• Aggression

  12 Months

• Craving

  4 weeks

Interventions

Antipsychotic DRUG

Participants will undergo a systematic neuropsychiatric assessement at regular intervals. Any change in medication, together with aggressive or dysfunctional behaviour will be continually recorded. The time period prior to the change in medication will be classified as control, the time after as case; therefore each patient becomes his own control.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Center for Inpatient Forensic Therapy (ZSFT: Zentrum für Stationäre ForensischeTherapie \[German\]), which is part of the Clinic for Forensic Psychiatry of the Psychiatric Hospital of the University of Zurich is Switzerland's largest forensic psychiatric clinic specializing in the treatment of imprisoned patients suffering from psychiatric disorders.

You may qualify if:

• Participants are competent to give informed consent.
• Participants are between 18 and 65 years of age.
• Diagnosis of schizophrenia DSM-5
• Violent crime in the course of a psychotic episode.
• German language proficiency

You may not qualify if:

• Low intelligence
• Current neurological disorder
• Substance induced psychotic disorder

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (1)

• Jabat M, Redlich Bossy M, Bausch Becker N, Keppeler HC, Machetanz L, Kirchebner J, Vetter S, Seifritz E, Egger ST. Capacity to give informed consent in patients with severe mental disorder in different treatment settings. Front Psychiatry. 2026 Jan 2;16:1709553. doi: 10.3389/fpsyt.2025.1709553. eCollection 2025.

  PMID: 41551193 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Stephan T. Egger, MD, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 11, 2023
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)