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

Tony Butler; Peter W Schofield; Lee Knight; Bianca Ton; David Greenberg; Rodney J Scott; Luke Grant; Anthony C Keech; Val Gebski; Jocelyn Jones; Andrew Ellis; Donald Weatherburn; Kay Wilhelm; Alison Jones; Alison Churchill; Stephen Allnutt; Philip B Mitchell; Duncan Chappell; Catherine D'Este; Dominic Villa; Vaughan Carr

doi:10.1136/bmjopen-2020-044656

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

BMJ Open. 2021 Sep 2;11(9):e044656. doi: 10.1136/bmjopen-2020-044656.

Authors

Tony Butler¹, Peter W Schofield^{2

3}, Lee Knight^{4

5}, Bianca Ton⁴, David Greenberg^{4

5}, Rodney J Scott², Luke Grant⁶, Anthony C Keech⁷, Val Gebski⁷, Jocelyn Jones⁸, Andrew Ellis^{4

5}, Donald Weatherburn⁴, Kay Wilhelm⁴, Alison Jones⁹, Alison Churchill¹⁰, Stephen Allnutt^{4

11}, Philip B Mitchell⁴, Duncan Chappell⁴, Catherine D'Este¹², Dominic Villa¹³, Vaughan Carr^{4

14}

Affiliations

¹ University of New South Wales, Sydney, New South Wales, Australia tbutler@unsw.edu.au.
² The University of Newcastle, Callaghan, New South Wales, Australia.
³ Neuropsychiatry Service, Hunter New England Mental Health, Newcastle, New South Wales, Australia.
⁴ University of New South Wales, Sydney, New South Wales, Australia.
⁵ Justice Health and Forensic Mental Health Network, Matraville, New South Wales, Australia.
⁶ Corrective Services New South Wales, Sydney, New South Wales, Australia.
⁷ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
⁸ National Drug Research Institute, Curtin University, Perth, Western Australia, Australia.
⁹ Fiona Stanley and Fremantle Hospitals Group, South Metropolitan Health Service, Perth, Western Australia, Australia.
¹⁰ Community Restorative Centre, Canterbury, New South Wales, Australia.
¹¹ Private practice psychiatrist, Lindfield, New South Wales, Australia.
¹² National Centre for Epidemiology and Population Health, The Australian National University, Canberra, Australian Capital Territory, Australia.
¹³ New Chambers, Sydney, New South Wales, Australia.
¹⁴ Monash University, Clayton, Victoria, Australia.

Abstract

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 anti-depressants 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.

Keywords: forensic psychiatry; impulse control disorders; public health.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aggression
Clinical Trials, Phase IV as Topic
Criminals*
Humans
Impulsive Behavior* / drug effects
Male
Multicenter Studies as Topic
New South Wales
Randomized Controlled Trials as Topic
Selective Serotonin Reuptake Inhibitors / therapeutic use
Sertraline* / therapeutic use

Substances

Sertraline
Selective Serotonin Reuptake Inhibitors

Associated data

ANZCTR/ACTRN12613000442707