Clinical trial NCT05939765: Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study.
Official title: Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Keywords: Schizophrenia
Pharmacologic Treatment
Forensic Treatment
Antipsychotics
Violent Behavior
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychopathology
timeFrame: 4 weeks
Secondary outcomes:
measure: Aggression
timeFrame: 12 Months
measure: Craving
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklinik Zürich
Study officials:
affiliation: University of Zurich
name: Stephan T. Egger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: