AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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

Other trials in Israel

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.

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 groups in NCT00797329
Study groupRoleWhat they receive
observationadult 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.

  1. 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.

  1. First posted25 Nov 2008 (estimated)
  2. Study startJul 2008

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in