Violent BehaviorNCT00797329
Biological and Cognitive Markers of Violent Behavior in Forensic Patients With Polysubstance Use: Retrospective Evaluation
An observational study of Violent Behavior and Polydrug Use, run by BeerYaakov Mental Health Center at 2 sites in Israel.
Trial summary
Aggressive behavior, both in the form of violence toward others (injury-inflicting or homicide) or toward oneself (suicide or self-injures) create problems of patient management, treatment and paroles. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men only
- Conditions the study is for
- Violent Behavior, Polydrug Use, Alcohol Abuse
- What is being tested?
- chart review
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2008to not given
- 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 19 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Age between 19-65 years; men with verified diagnoses of alcohol and polydrug use according to DSM-IV criteria; hospitalized in maximum security department between 2002 - 2008.
Who may be able to join
- Age between 19-65 years
- Men with verified diagnoses of alcohol and polydrug use according to DSM-IV criteria, underwent cholesterol and cognitive assessment, while being incarcerated in maximum-security forensic facility
Who cannot join
- Subjects suffering from any clinically significant metabolic disorder (e.g. diabetes, hypo-hyperthiorioidosis, et ctr)
- Subjects suffering from clinically significant infectional disorder (e.g. tuberculosis, pneumonia, AIDS, active HCV et ctr)
- Subjects starving or suffering from severe hepatic or kidney dysfunction and insufficiency
- patients with comorbid diagnoses of schizophrenia, schizoaffective disorder and bipolar mood disorder
- patients with comorbide mild mental retardation or epilepsy
- patients with using cholesterol lowering agent
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Beer-Yaacov MHC
Beer Yaacov, 70350
BeerYaakov MHC
Beer Yaakov, 70350
About this study
Aggressive behavior, both in the form of violence toward others (injury-inflicting or homicide) or toward oneself (suicide or self-injures) create problems of patient management, treatment and paroles.
Biological causes of violent crime were hypothesized by Eysenck (1978), who believed that criminality resulted from a nervous system distinct from that of most people.
Read more
The prefrontal cortex, regulates planning of motor acts and executive functions, which are critical for inhibitory ability and control of impulsive outburst were found to be impaired in violent subjects (Hoaken et al, 2003; Blair, 2001; Brower and Price, 2001; Filley et al, 2001; Raine et al, 2000; George et al, 2004; Dolan and Park, 2002; Stevens et al, 2003; Raine and Yang, 2006), especially in impulsive offenders murderers (Raine et al, 1997; 1998). Violence act influenced by nonplaning outboards definite as impulsive aggression (Linnoila and Charney, 1999), which one of the most important factor influenced by dangerous behavior in general (for review: Skodol, 1998, Moeller et al, 2001; Pontius, 2000; 2004; Siever, 2008).
Cholesterol and fats have many roles and may influence brain function and behavior through modification of membranes; myelin; enzyme function; absorption and transport of fat-soluble vitamins and toxins; and steroid hormones and through effects on production, reuptake, or metabolism of neurotransmitters (Boston et al, 1996).
Since 80-th a strong association was found between low cholesterol levels and violent behavior, an association that was not due to age, race, sex, or diagnosis (Mufti et al, 1998; New et al, 1999; Alvarez et al, 2000; Golomb et al, 2000; Hillbrand et al, 2000; Troisi and D'Argenio, 2006; Chakrabarat and Sinha, 2006).
Associations between violent behavior, cognitive functioning and total cholesterol level were contradicted with difference in samples and behavioral parameters: homicide, homicide attempts, rape, physical or verbal aggression, complete suicide or suicide attempts, only partially accounted for each measure of behaviors, suggesting that further investigation is warranted. Because of the inconsistencies in the available data, we studied retrospectively a group of criminal offenders with alcohol and drug use. Our analysis of lipid constituents in serum focused on TC, HDL, LDL, and TG.
Significance of the study. It is possible that cholesterol profile is a biomarker and potential predictor of violent in patients with polydrug use.
The purpose of this retrospective study is to investigate the correlations between cholesterol and cognitive profiles in psychiatric patients with violent behaviour. The demographic and criminal records, clinical characteristics, cholesterol profiles, and cognitive performance data of these patients will be will be intercorrelated.
- Conditions
- Violent Behavior, Polydrug Use, Alcohol Abuse
- Being tested
- chart review
- Keywords
- psychiatric patients with violent behavior
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chart reviewOther
- cholesterol
- cognitive profiles
- violent behavior
| Study group | Role | What they receive |
|---|---|---|
| observation | adult men with alcohol and polydrug use according to DSM-IV criteria, hospitalized in maximum security department between 2002 - 2008 Receives: Other: chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this retrospective study is to investigate the correlations between cholesterol and cognitive profiles in psychiatric patients with violent behaviour.
Measured: 2008-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violent BehaviorStudies 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797329
- Sponsor's protocol ID
- 222CTIL
- Status last verified
- Nov 2008
- First submitted
- 23 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Cognitive Markers of Violent Behavior in Forensic Patients With Polysubstance Use: Retrospective Evaluation
- ClinicalTrials.gov ID
- NCT00797329
- Acronym / sponsor ID
- 222CTIL
- Conditions
- Violent Behavior, Polydrug Use, Alcohol Abuse
- Keywords
- psychiatric patients with violent behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Study start
- Jul 2008
- First posted
- 25 Nov 2008 (estimated)
- 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.
Aggressive behavior, both in the form of violence toward others (injury-inflicting or homicide) or toward oneself (suicide or self-injures) create problems of patient management, treatment and paroles.
Biological causes of violent crime were hypothesized by Eysenck (1978), who believed that criminality resulted from a nervous system distinct from that of most people.
The prefrontal cortex, regulates planning of motor acts and executive functions, which are critical for inhibitory ability and control of impulsive outburst were found to be impaired in violent subjects (Hoaken et al, 2003; Blair, 2001; Brower and Price, 2001; Filley et al, 2001; Raine et al, 2000; George et al, 2004; Dolan and Park, 2002; Stevens et al, 2003; Raine and Yang, 2006), especially in impulsive offenders murderers (Raine et al, 1997; 1998). Violence act influenced by nonplaning outboards definite as impulsive aggression (Linnoila and Charney, 1999), which one of the most important factor influenced by dangerous behavior in general (for review: Skodol, 1998, Moeller et al, 2001; Pontius, 2000; 2004; Siever, 2008).
Cholesterol and fats have many roles and may influence brain function and behavior through modification of membranes; myelin; enzyme function; absorption and transport of fat-soluble vitamins and toxins; and steroid hormones and through effects on production, reuptake, or metabolism of neurotransmitters (Boston et al, 1996).
Since 80-th a strong association was found between low cholesterol levels and violent behavior, an association that was not due to age, race, sex, or diagnosis (Mufti et al, 1998; New et al, 1999; Alvarez et al, 2000; Golomb et al, 2000; Hillbrand et al, 2000; Troisi and D'Argenio, 2006; Chakrabarat and Sinha, 2006).
Associations between violent behavior, cognitive functioning and total cholesterol level were contradicted with difference in samples and behavioral parameters: homicide, homicide attempts, rape, physical or verbal aggression, complete suicide or suicide attempts, only partially accounted for each measure of behaviors, suggesting that further investigation is warranted. Because of the inconsistencies in the available data, we studied retrospectively a group of criminal offenders with alcohol and drug use. Our analysis of lipid constituents in serum focused on TC, HDL, LDL, and TG.
Significance of the study. It is possible that cholesterol profile is a biomarker and potential predictor of violent in patients with polydrug use.
The purpose of this retrospective study is to investigate the correlations between cholesterol and cognitive profiles in psychiatric patients with violent behaviour. The demographic and criminal records, clinical characteristics, cholesterol profiles, and cognitive performance data of these patients will be will be intercorrelated.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | Other: chart reviewadult men with alcohol and polydrug use according to DSM-IV criteria, hospitalized in maximum security department between 2002 - 2008 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age between 19-65 years; men with verified diagnoses of alcohol and polydrug use according to DSM-IV criteria; hospitalized in maximum security department between 2002 - 2008.
Key inclusion criteria (2 listed)
- Age between 19-65 years
- Men with verified diagnoses of alcohol and polydrug use according to DSM-IV criteria, underwent cholesterol and cognitive assessment, while being incarcerated in maximum-security forensic facility
Key exclusion criteria (6 listed)
- Subjects suffering from any clinically significant metabolic disorder (e.g. diabetes, hypo-hyperthiorioidosis, et ctr)
- Subjects suffering from clinically significant infectional disorder (e.g. tuberculosis, pneumonia, AIDS, active HCV et ctr)
- Subjects starving or suffering from severe hepatic or kidney dysfunction and insufficiency
- patients with comorbid diagnoses of schizophrenia, schizoaffective disorder and bipolar mood disorder
- patients with comorbide mild mental retardation or epilepsy
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 |
|---|---|---|
| chart review* cholesterol * cognitive profiles * violent behavior | Other | observation |
Primary outcome
The purpose of this retrospective study is to investigate the correlations between cholesterol and cognitive profiles in psychiatric patients with violent behaviour.
Time frame: 2008-2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Violent Behavior and Polydrug Use, run by BeerYaakov Mental Health Center at 2 sites in Israel.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
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?
The purpose of this retrospective study is to investigate the correlations between cholesterol and cognitive profiles in psychiatric patients with violent behaviour. (time frame: 2008-2009). 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 25 Nov 2008.