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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939765
• Other study ID #: AiW-TlG
• Status: Recruiting
• Start date: August 2, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: September 2023
• Source: Psychiatric University Hospital, Zurich
• Contact: Stephan T Egger, MD, PhD
• Phone: +41583843473
• Email: stephan.egger[@]pukzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Antipsychotic
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.

Locations

Country	Name	City	State
Switzerland	Psychiatrische Universitätsklinik Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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