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

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ClinicalTrials.gov Identifier: NCT05939765
Recruitment Status : Recruiting
First Posted : July 11, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Stephan T. Egger, Psychiatric University Hospital, Zurich

Study Description
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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.

Condition or disease Intervention/treatment
Schizophrenia 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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study
Actual Study Start Date : August 2, 2023
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Psychopathology [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Aggression [ Time Frame: 12 Months ]
    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.

  2. Craving [ Time Frame: 4 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05939765


Contacts
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Contact: Stephan T Egger, MD, PhD +41583843473 stephan.egger@pukzh.ch
Contact: Mona Redlich Bossy, MSc +41523049295 mona.redlichbossy@pukzh.ch

Locations
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Switzerland
Psychiatrische Universitätsklinik Zürich Recruiting
Zürich, Switzerland, 8032
Contact: Stephan T Egger, MD, PhD    +41583843473    stephan.egger@puk.zh.ch   
Contact: Johannes Kirchebner, MD    +41523049335    johannes.kirchebner@puk.zh.ch   
Sponsors and Collaborators
Psychiatric University Hospital, Zurich
Investigators
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Principal Investigator: Stephan T. Egger, MD, PhD University of Zurich
More Information
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Responsible Party: Stephan T. Egger, Principal Investigator, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT05939765    
Other Study ID Numbers: AiW-TlG
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephan T. Egger, Psychiatric University Hospital, Zurich:
Schizophrenia
Pharmacologic Treatment
Forensic Treatment
Antipsychotics
Violent Behavior
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs