SchizophreniaNCT05939765
Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study.
An observational study of Schizophrenia, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Antipsychotic
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Low intelligence
- Current neurological disorder
- Substance induced psychotic disorder
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatrische Universitätsklinik Zürich
Zurich, Canton of Zurich, 8032
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Antipsychotic
- Keywords
- Schizophrenia, Pharmacologic Treatment, Forensic Treatment, Antipsychotics, Violent Behavior
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipsychoticDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: After screening, not enough participants fulfilled the inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan T. Egger, Psychiatric University Hospital, Zurich
- Investigators
- Stephan T. Egger, MD, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939765
- Sponsor's protocol ID
- AiW-TlG
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41551193
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Treatment in Legal Offenders With Schizophrenia, a Prospective Observational Mirror Image Study
- ClinicalTrials.gov ID
- NCT05939765
- Acronym / sponsor ID
- AiW-TlG
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Pharmacologic Treatment, Forensic Treatment, Antipsychotics, Violent Behavior
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: After screening, not enough participants fulfilled the inclusion criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Low intelligence
- Current neurological disorder
- Substance induced psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntipsychoticParticipants 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. | Drug | – |
Primary outcome
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.
2 secondary outcomes
Aggression
Time frame: 12 Months
Craving
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 41551193Jabat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan T. Egger, MD, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychopathology (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05939765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.