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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Antipsychotic

Detailed Description

Patients with a schizophrenia spectrum disorder who commit violent crimes appear to have some distinguishing characteristics. The current view is that crime committed in the course of a psychiatric illness, particularly schizophrenia, is treatable and preventable. Nonetheless, treatment options for this patient group are sparse. The evidence regarding the efficacy and safety of such treatments is practically nonexistent. In practice therapeutic options are limited to medication and even here there is only one antipsychotic (clozapine) which has The current view is that crime committed during a psychiatric illness, particularly schizophrenia, is treatable and preventable. Nonetheless, treatment options for this patient group are sparse. The evidence regarding the efficacy and safety of such treatments is practically nonexistent. In practice, therapeutic options are limited to medication; even here, almost no controlled clinical trials are investigating this issue.

In clinical practice, selecting specific psychopharmacological treatments for patients with schizophrenia showing violent or aggressive behavior is particularly demanding. The lack of evidence regarding treatments for this particular group is partly attributable to their dual vulnerability and the consequent restrictions on clinical and experimental trials. Paradoxically, the efforts to ensure the safety and rights of these patients put them at a disadvantage, as they have no access to evidence-based treatment for their condition. Therefore, at best, they experience limited or slow improvement in their condition or, at worst, receive potentially ineffective or deleterious treatment.

To address the lack of evidence regarding the efficacy and safety of antipsychotic treatment options for this particular population, the investigators have designed a prospective observational study with evaluation in a mirror image design. This reduces confounders at the level of a randomized controlled trial, allowing for robust statistical analysis.

• Study Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8032
      • Psychiatrische Universitätsklinik Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria

• 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

Exclusion criteria

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggression	The Modified Overt Aggression Scale (MOAS) is a four-part behavior rating scale used to evaluate and document the frequency and severity of aggressive episodes. It ranges 0 to 100: higher scores mean more severe aggression. Aggression and aggressive behavior as assessed by the MOAS.	12 Months
Craving	The Yale Craving Scale (YCS) is a psychometric scale for assessing smoking and drinking urges. Total scores range from 0 to 40, with higher scores indicating greater dependence. Change from baseline in craving on the YCS.	4 weeks

Collaborators and Investigators

• Sponsor: Psychiatric University Hospital, Zurich
• Investigators: Principal Investigator: Stephan T. Egger, MD, PhD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: July 1, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Violent Behavior; Schizophrenia; Antipsychotics; Pharmacologic Treatment; Forensic Treatment
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Antipsychotic Agents
• Other Study ID Numbers: AiW-TlG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No