RecruitingPhase 4ACTRN12613000442707

Reducing impulsivity in repeat violent offenders using a selective serotonin reuptake inhibitor (sertraline)


Sponsor

University of NSW

Enrollment

460 participants

Start Date

Oct 21, 2013

Study Type

Interventional

Conditions

Summary

Violence is a leading cause of death and injury worldwide and a large percentage of prison inmates have histories of violent offending. Numerous studies attest to a strong association between poor impulse control (impulsivity) and violent crime. Impulsivity has been shown to be associated with reduced tone in neural pathways within the brain for which serotonin is the principal neurotransmitter. In a number of studies of impulsive-aggressive individuals, the administration of selective serotonin reuptake inhibitors (SSRIs) has been associated with reduced aggression, impulsivity and depression. To date, there has been no systematic study of the potential benefits of SSRIs for incarcerated impulsive violent offenders who are at high risk of repeat offending. This trial will examine the effectiveness of treatment with an SSRI in impulsive violent offenders on reoffending using a double blind RCT design.


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Research shows a strong link between poor impulse control and violent behaviour. People with impulsivity have reduced activity in the brain's serotonin pathways — the chemical system that helps regulate mood and self-control. This trial is testing whether sertraline, a commonly prescribed antidepressant from the SSRI class, can improve impulse control in repeat violent male offenders and reduce the likelihood of future violent offending. It uses a rigorous double-blind design, meaning neither participants nor researchers know who receives the real drug. You may be eligible if: - You are a male 18 years of age or older (up to 70) - You have been convicted of 2 or more violent offences - You score 70 or above on the Barratt Impulsiveness Scale - You are medically fit and able to provide informed consent You may NOT be eligible if: - You are currently taking an SSRI, SNRI, or tricyclic antidepressant - You have had an adverse reaction to SSRIs before - You are taking antipsychotic medication - You have a severe mental illness or are considered at high risk of suicide - You are expecting to receive a custodial prison sentence - You have significant kidney or liver problems - You have been convicted of murder or child sexual assault - You are about to be deported or move to a remote area Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention consists of 100mg sertraline or placebo sertraline taken orally, once per day for 12 months duration. The medication used in this trial will be in tablet form. Sertraline is an anti-de

Intervention consists of 100mg sertraline or placebo sertraline taken orally, once per day for 12 months duration. The medication used in this trial will be in tablet form. Sertraline is an anti-depressant of the selective serotonin reuptake inhibitor (SSRI) class. It is primarily used to treat major depression in adults as well as obsessive-compulsive, panic, and social anxiety disorders in both adults and children. According to the Australian Statistics on Medicines 2007 (latest available data), SSRIs were the most commonly prescribed anti-depressant in Australia with over 8.5 million scripts issued in that year. Among SSRIs, sertraline was the most commonly prescribed anti-depressant. The selected dose is 100mg/day which is common when used as an antidepressant. Sertraline may be prescribed up to 200mg/day.


Locations(1)

NSW, Australia

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ACTRN12613000442707


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