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

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dc.contributor.authorButler, T.
dc.contributor.authorSchofield, P.W.
dc.contributor.authorKnight, L.
dc.contributor.authorTon, B.
dc.contributor.authorGreenberg, D.
dc.contributor.authorScott, R.J.
dc.contributor.authorGrant, L.
dc.contributor.authorKeech, A.C.
dc.contributor.authorGebski, V.
dc.contributor.authorJones, J.
dc.contributor.authorEllis, A.
dc.contributor.authorWeatherburn, D.
dc.contributor.authorWilhelm, K.
dc.contributor.authorJones, A.
dc.contributor.authorChurchill, A.
dc.contributor.authorAllnutt, S.
dc.contributor.authorMitchell, P.B.
dc.contributor.authorChappell, D.
dc.contributor.authorDeste, C.
dc.contributor.authorVilla, D.
dc.contributor.authoret al.
dc.date.issued2021
dc.description.abstractIntroduction 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.
dc.description.statementofresponsibilityTony 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
dc.identifier.citationBMJ Open, 2021; 11(9):e044656-e044656
dc.identifier.doi10.1136/bmjopen-2020-044656
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidJones, A. [0000-0002-1105-6195]
dc.identifier.urihttps://hdl.handle.net/2440/139180
dc.language.isoen
dc.publisherBMJ
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/533559
dc.rights© 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.
dc.source.urihttps://doi.org/10.1136/bmjopen-2020-044656
dc.subjectSelective serotonin reuptake inhibitors (SSRIs)
dc.subjectcriminal justice population
dc.subject.meshHumans
dc.subject.meshSertraline
dc.subject.meshAggression
dc.subject.meshImpulsive Behavior
dc.subject.meshHealth Services, Indigenous
dc.subject.meshMale
dc.subject.meshMulticenter Studies as Topic
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshCriminals
dc.subject.meshNative Hawaiian or Other Pacific Islander
dc.titleSertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): Protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial
dc.typeJournal article
pubs.publication-statusPublished

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