SCHIZOPHRENIA 1 (Disorder)NCT07585656
Comparison of the Italian and U.S. Forensic Models for Dual-diagnosis Offenders: a 3-year Longitudinal Study
An observational study of SCHIZOPHRENIA 1 (Disorder) and Substance Abuse, run by University of Bari.
Trial summary
This study aims to compare the Italian and U.S. forensic models in the treatment of offenders with dual diagnosis through a three-year longitudinal design. In Italy, the closure of Judicial Psychiatric Hospitals following Law 81/2014 led to the establishment of a community-based forensic system centered on REMS… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Substance Abuse
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult offenders with mental disorders recruited from forensic psychiatric care systems in Italy and California. Participants are enrolled at the time of the application of a security measure or upon admission to a forensic facility, including both custodial and non-custodial settings. In the Italian cohort, participants include individuals placed under security measures within the National Health Service, such as those admitted to REMS or managed in community-based forensic or psychiatric services. This group reflects the community-oriented Italian forensic model, characterized by rehabilitative pathways and integration with territorial mental health services. In the California cohort, participants are recruited from high-security forensic hospitals and community forensic programs under the Department of State Hospitals, including individuals deemed incompetent to stand trial (IST) or not guilty by reason of insanity (NGRI). This population reflects a h
Who may be able to join
- Adults aged 18 years or older.
- Individuals admitted to forensic psychiatric care in Italy or California.
- Presence of a diagnosed mental disorder according to DSM-5 / ICD criteria.
- Presence of a current or lifetime Substance Use Disorder, consistent with a dual-diagnosis condition.
- Placement in one of the study settings:
- Italy: REMS or other forensic/community facilities under custodial or non-custodial security measures; California: Department of State Hospitals forensic facilities.
- Ability to provide written informed consent, or consent provided through a legal guardian when applicable.
- Availability for longitudinal follow-up at 12, 24, and 36 months.
Who cannot join
- Absence of a confirmed psychiatric disorder.
- Absence of current or lifetime Substance Use Disorder.
- Non-forensic psychiatric patients without criminal justice involvement.
- Severe cognitive impairment or neurological condition preventing valid assessment.
- Acute medical or psychiatric instability that makes participation temporarily impossible.
- Inability to complete the assessment procedures, even with support or adapted administration.
- Refusal to participate or withdrawal of informed consent. Insufficient clinical, forensic, or follow-up data for longitudinal analysis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Felice F. Carabellese, Medical doctor, Full Professor contact
About this study
Official title: Comparison of the Italian and US Forensic Models Regarding Dual Diagnosis Offenders: a 3-year Longitudinal Study
This study aims to compare the Italian and U.S. forensic models in the treatment of offenders with dual diagnosis through a three-year longitudinal design. In Italy, the closure of Judicial Psychiatric Hospitals following Law 81/2014 led to the establishment of a community-based forensic system centered on REMS (Residences for the Execution of Security Measures), integrated within the National Health Service. This model seeks to limit institutionalization and promote rehabilitative pathways in community settings. However, it continues to face challenges related to limited bed availability, waiting lists, and the complex management of social dangerousness. In contrast, the U.S. system, particularly in California, is characterized by high-security forensic psychiatric hospitals with large capacities, but also presents issues such as prolonged hospitalizations, an aging patient population, and a high prevalence of substance use disorders.
Dual diagnosis, defined as the co-occurrence of psychiatric disorders and substance use disorders, is highly prevalent in forensic populations and is associated with increased clinical complexity, higher risk of recidivism, and poorer treatment outcomes. Neurobiological and psychological mechanisms underlying addiction-including dysfunctions in the dopaminergic reward system, craving processes, and impairments in executive functioning-contribute to reduced behavioral control and increased impulsivity. Theoretical models such as the self-medication hypothesis and multifactorial frameworks suggest that substance use may both exacerbate psychiatric symptoms and represent an attempt to regulate them.
Read more
Given these complexities, integrated treatment approaches that combine psychiatric care and addiction interventions are essential, particularly in forensic settings. The present study includes offenders with mental illness in forensic care systems in Italy and California, encompassing both custodial and non-custodial settings. Participants will be followed over a three-year period, with assessments conducted at 12, 24, and 36 months. The methodology involves the use of standardized instruments to evaluate psychopathological severity, global functioning, risk of violent recidivism, protective factors, treatment adherence, impulsivity, and substance use. Data on clinical outcomes, antisocial behaviors, and discharge conditions will also be collected.
The primary objectives of the study are to describe and compare the clinical, demographic, and criminological profiles of forensic populations with dual diagnosis; to examine treatment pathways and outcomes; to identify indicators of treatment effectiveness; and to evaluate both risk and protective prognostic factors, as well as their predictive value for recidivism and clinical trajectories.
The expected impact of the study lies in improving the understanding of differences between community-based and hospital-based forensic models, with the goal of identifying integrated strategies capable of enhancing rehabilitation, reducing recidivism, and improving long-term outcomes. Findings may contribute to the development of more effective and individualized treatment approaches, as well as inform health and judicial policies aimed at better integrating clinical care and risk management in dual diagnosis forensic populations.
- Conditions
- SCHIZOPHRENIA 1 (Disorder), Substance Abuse
- Keywords
- forensic treatment, SUD, forensic psychiatry
- Medical subject headings
- Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Violent Recidivism Risk
The risk of violent recidivism will be assessed longitudinally using structured professional judgment approaches, integrating dynamic clinical, historical, and risk management factors. Changes over time will be analyzed to evaluate the impact of treatment and system-related variables on future violence risk.
Measured: from enrollment at 3 years
Clinical Improvement (Psychopathology)
Clinical severity will be measured through standardized psychiatric rating scales, capturing changes in psychopathological symptoms across the follow-up period. This outcome reflects the effectiveness of treatment in reducing symptom burden and improving mental stability.
Measured: from enrollment to 3 years
Substance Use Severity and Relapse
Substance use severity and relapse will be evaluated using validated screening tools and clinical data, focusing on patterns of use, reduction, and recurrence over time. This outcome is central to understanding the trajectory of dual diagnosis and its interaction with clinical and forensic outcomes.
Measured: from enrollment to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felice Carabellese, University of Bari
- Investigators
- Felice F. Carabellese, Medical doctor, Full Professor, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585656
- Sponsor's protocol ID
- prot. 2237/CEL
- Status last verified
- Mar 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Italian and US Forensic Models Regarding Dual Diagnosis Offenders: a 3-year Longitudinal Study
- ClinicalTrials.gov ID
- NCT07585656
- Acronym / sponsor ID
- prot. 2237/CEL
- Conditions
- SCHIZOPHRENIA 1 (Disorder), Substance Abuse
- Keywords
- forensic treatment, SUD, forensic psychiatry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 14 May 2026 (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.
This study aims to compare the Italian and U.S. forensic models in the treatment of offenders with dual diagnosis through a three-year longitudinal design. In Italy, the closure of Judicial Psychiatric Hospitals following Law 81/2014 led to the establishment of a community-based forensic system centered on REMS (Residences for the Execution of Security Measures), integrated within the National Health Service. This model seeks to limit institutionalization and promote rehabilitative pathways in community settings. However, it continues to face challenges related to limited bed availability, waiting lists, and the complex management of social dangerousness. In contrast, the U.S. system, particularly in California, is characterized by high-security forensic psychiatric hospitals with large capacities, but also presents issues such as prolonged hospitalizations, an aging patient population, and a high prevalence of substance use disorders.
Dual diagnosis, defined as the co-occurrence of psychiatric disorders and substance use disorders, is highly prevalent in forensic populations and is associated with increased clinical complexity, higher risk of recidivism, and poorer treatment outcomes. Neurobiological and psychological mechanisms underlying addiction-including dysfunctions in the dopaminergic reward system, craving processes, and impairments in executive functioning-contribute to reduced behavioral control and increased impulsivity. Theoretical models such as the self-medication hypothesis and multifactorial frameworks suggest that substance use may both exacerbate psychiatric symptoms and represent an attempt to regulate them.
Given these complexities, integrated treatment approaches that combine psychiatric care and addiction interventions are essential, particularly in forensic settings. The present study includes offenders with mental illness in forensic care systems in Italy and California, encompassing both custodial and non-custodial settings. Participants will be followed over a three-year period, with assessments conducted at 12, 24, and 36 months. The methodology involves the use of standardized instruments to evaluate psychopathological severity, global functioning, risk of violent recidivism, protective factors, treatment adherence, impulsivity, and substance use. Data on clinical outcomes, antisocial behaviors, and discharge conditions will also be collected.
The primary objectives of the study are to describe and compare the clinical, demographic, and criminological profiles of forensic populations with dual diagnosis; to examine treatment pathways and outcomes; to identify indicators of treatment effectiveness; and to evaluate both risk and protective prognostic factors, as well as their predictive value for recidivism and clinical trajectories.
The expected impact of the study lies in improving the understanding of differences between community-based and hospital-based forensic models, with the goal of identifying integrated strategies capable of enhancing rehabilitation, reducing recidivism, and improving long-term outcomes. Findings may contribute to the development of more effective and individualized treatment approaches, as well as inform health and judicial policies aimed at better integrating clinical care and risk management in dual diagnosis forensic populations.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult offenders with mental disorders recruited from forensic psychiatric care systems in Italy and California. Participants are enrolled at the time of the application of a security measure or upon admission to a forensic facility, including both custodial and non-custodial settings. In the Italian cohort, participants include individuals placed under security measures within the National Health Service, such as those admitted to REMS or managed in community-based forensic or psychiatric services. This group reflects the community-oriented Italian forensic model, characterized by rehabilitative pathways and integration with territorial mental health services. In the California cohort, participants are recruited from high-security forensic hospitals and community forensic programs under the Department of State Hospitals, including individuals deemed incompetent to stand trial (IST) or not guilty by reason of insanity (NGRI). This population reflects a h
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Individuals admitted to forensic psychiatric care in Italy or California.
- Presence of a diagnosed mental disorder according to DSM-5 / ICD criteria.
- Presence of a current or lifetime Substance Use Disorder, consistent with a dual-diagnosis condition.
- Placement in one of the study settings:
Key exclusion criteria (7 listed)
- Absence of a confirmed psychiatric disorder.
- Absence of current or lifetime Substance Use Disorder.
- Non-forensic psychiatric patients without criminal justice involvement.
- Severe cognitive impairment or neurological condition preventing valid assessment.
- Acute medical or psychiatric instability that makes participation temporarily impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Violent Recidivism Risk
Time frame: from enrollment at 3 years
The risk of violent recidivism will be assessed longitudinally using structured professional judgment approaches, integrating dynamic clinical, historical, and risk management factors. Changes over time will be analyzed to evaluate the impact of treatment and system-related variables on future violence risk.
Clinical Improvement (Psychopathology)
Time frame: from enrollment to 3 years
Clinical severity will be measured through standardized psychiatric rating scales, capturing changes in psychopathological symptoms across the follow-up period. This outcome reflects the effectiveness of treatment in reducing symptom burden and improving mental stability.
Substance Use Severity and Relapse
Time frame: from enrollment to 3 years
Substance use severity and relapse will be evaluated using validated screening tools and clinical data, focusing on patterns of use, reduction, and recurrence over time. This outcome is central to understanding the trajectory of dual diagnosis and its interaction with clinical and forensic outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- The Italian general psychiatry and forensic psychiatry treatment model: a unique storyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Felice F. Carabellese, Medical doctor, Full Professor contact
Felice F. Carabellese, Medical doctor, Full Professor principal investigator
University of Bari Aldo Moro
Questions about this trial
What is this clinical trial studying?
An observational study of SCHIZOPHRENIA 1 (Disorder) and Substance Abuse, run by University of Bari.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felice F. Carabellese, Medical doctor, Full Professor (+39330673152, felicefrancesco.carabellese@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Violent Recidivism Risk (time frame: from enrollment at 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.