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Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial

INTRODUCTION: Considerable evidence supports an association between poor impulse control (impulsivity) and violent crime. Furthermore, impulsivity and aggression has been associated with reduced levels of serotonergic activity in the brain. Selective serotonin reuptake inhibitors (SSRIs) are a class...

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Autores principales: Butler, Tony, Schofield, Peter W, Knight, Lee, Ton, Bianca, Greenberg, David, Scott, Rodney J, Grant, Luke, Keech, Anthony C, Gebski, Val, Jones, Jocelyn, Ellis, Andrew, Weatherburn, Donald, Wilhelm, Kay, Jones, Alison, Churchill, Alison, Allnutt, Stephen, Mitchell, Philip B, Chappell, Duncan, D'Este, Catherine, Villa, Dominic, Carr, Vaughan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8413868/
https://www.ncbi.nlm.nih.gov/pubmed/34475139
http://dx.doi.org/10.1136/bmjopen-2020-044656
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author Butler, Tony
Schofield, Peter W
Knight, Lee
Ton, Bianca
Greenberg, David
Scott, Rodney J
Grant, Luke
Keech, Anthony C
Gebski, Val
Jones, Jocelyn
Ellis, Andrew
Weatherburn, Donald
Wilhelm, Kay
Jones, Alison
Churchill, Alison
Allnutt, Stephen
Mitchell, Philip B
Chappell, Duncan
D'Este, Catherine
Villa, Dominic
Carr, Vaughan
author_facet Butler, Tony
Schofield, Peter W
Knight, Lee
Ton, Bianca
Greenberg, David
Scott, Rodney J
Grant, Luke
Keech, Anthony C
Gebski, Val
Jones, Jocelyn
Ellis, Andrew
Weatherburn, Donald
Wilhelm, Kay
Jones, Alison
Churchill, Alison
Allnutt, Stephen
Mitchell, Philip B
Chappell, Duncan
D'Este, Catherine
Villa, Dominic
Carr, Vaughan
author_sort Butler, Tony
collection PubMed
description INTRODUCTION: Considerable evidence supports an association between poor impulse control (impulsivity) and violent crime. Furthermore, impulsivity and aggression has been associated with reduced levels of serotonergic activity in the brain. Selective serotonin reuptake inhibitors (SSRIs) are a class of anti­depressants that aim to regulate brain serotonin concentrations. Several small studies in psychiatric populations have administered SSRIs to impulsive­–aggressive individuals, resulting in reduced impulsivity, anger, aggression and depression. However, no clinical trial has been undertaken in a criminal justice population. This protocol describes the design and implementation of the first systematic study of the potential benefits of SSRIs in impulsive­­–violent offenders who are at high risk of reoffending. METHODS AND ANALYSIS: A randomised, double-blinded, multicentre trial to test the clinical efficacy of an SSRI, sertraline hydrochloride, compared with placebo on recidivism and behavioural measures (including impulsivity, anger, aggression, depression and self-reported offending) over 12 months. 460 participants with histories of violence and screening positive for impulsivity are recruited at several local courts and correctional service offices in New South Wales, Australia. ETHICS AND DISSEMINATION: Results will be submitted for publication in a peer-reviewed journal. Possible implications of the effectiveness of this pharmacological intervention include economic benefits of reducing prison costs and societal benefits of improving safety. This study has received ethical approval from the University of New South Wales, Aboriginal Health & Medical Research Council, Corrective Services NSW and the NSW Justice Health and Forensic Mental Health Network. TRIAL REGISTRATION NUMBER: ACTRN12613000442707.
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spelling pubmed-84138682021-09-22 Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial Butler, Tony Schofield, Peter W Knight, Lee Ton, Bianca Greenberg, David Scott, Rodney J Grant, Luke Keech, Anthony C Gebski, Val Jones, Jocelyn Ellis, Andrew Weatherburn, Donald Wilhelm, Kay Jones, Alison Churchill, Alison Allnutt, Stephen Mitchell, Philip B Chappell, Duncan D'Este, Catherine Villa, Dominic Carr, Vaughan BMJ Open Public Health INTRODUCTION: Considerable evidence supports an association between poor impulse control (impulsivity) and violent crime. Furthermore, impulsivity and aggression has been associated with reduced levels of serotonergic activity in the brain. Selective serotonin reuptake inhibitors (SSRIs) are a class of anti­depressants that aim to regulate brain serotonin concentrations. Several small studies in psychiatric populations have administered SSRIs to impulsive­–aggressive individuals, resulting in reduced impulsivity, anger, aggression and depression. However, no clinical trial has been undertaken in a criminal justice population. This protocol describes the design and implementation of the first systematic study of the potential benefits of SSRIs in impulsive­­–violent offenders who are at high risk of reoffending. METHODS AND ANALYSIS: A randomised, double-blinded, multicentre trial to test the clinical efficacy of an SSRI, sertraline hydrochloride, compared with placebo on recidivism and behavioural measures (including impulsivity, anger, aggression, depression and self-reported offending) over 12 months. 460 participants with histories of violence and screening positive for impulsivity are recruited at several local courts and correctional service offices in New South Wales, Australia. ETHICS AND DISSEMINATION: Results will be submitted for publication in a peer-reviewed journal. Possible implications of the effectiveness of this pharmacological intervention include economic benefits of reducing prison costs and societal benefits of improving safety. This study has received ethical approval from the University of New South Wales, Aboriginal Health & Medical Research Council, Corrective Services NSW and the NSW Justice Health and Forensic Mental Health Network. TRIAL REGISTRATION NUMBER: ACTRN12613000442707. BMJ Publishing Group 2021-09-02 /pmc/articles/PMC8413868/ /pubmed/34475139 http://dx.doi.org/10.1136/bmjopen-2020-044656 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Public Health
Butler, Tony
Schofield, Peter W
Knight, Lee
Ton, Bianca
Greenberg, David
Scott, Rodney J
Grant, Luke
Keech, Anthony C
Gebski, Val
Jones, Jocelyn
Ellis, Andrew
Weatherburn, Donald
Wilhelm, Kay
Jones, Alison
Churchill, Alison
Allnutt, Stephen
Mitchell, Philip B
Chappell, Duncan
D'Este, Catherine
Villa, Dominic
Carr, Vaughan
Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
title Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
title_full Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
title_fullStr Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
title_full_unstemmed Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
title_short Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
title_sort sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (reinvest): protocol for a phase iv, double-blind, placebo-controlled, randomised clinical trial
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8413868/
https://www.ncbi.nlm.nih.gov/pubmed/34475139
http://dx.doi.org/10.1136/bmjopen-2020-044656
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