Sertraline to reduce recidivism in impulsive violent offenders (ReINVEST): a randomised double blind clinical trial.

Background: Biological studies suggest serotonin modulation via selective serotonin reuptake inhibitors (SSRIs) might reduce impulsive violence, however, robust evidence in offender populations is limited. We aimed to determine whether sertraline reduces violent reoffending compared with placebo in highly impulsive men with recurrent violent offending. Methods: We conducted a double-blind, placebo-controlled, randomised clinical trial in community settings in New South Wales, Australia. Eligible participants were men aged 18 years or older with ≥2 prior violent convictions and a Barratt Impulsiveness Scale score ≥70. Following a 4-week single-blind active run-in phase with sertraline, participants were randomly assigned (1:1, minimization stratified by key factors) to receive oral sertraline (100 mg daily) or matching placebo for 12 months. The primary outcome was the first convicted violent offence within 12 months, assessed via linkage to the state Reoffending Database. The primary analysis followed the intention-to-treat principle. The trial is registered with ANZCTR (ACTRN12613000442707) and is closed to new participants. Findings: Between October 28, 2013, and July 13, 2021, 630 eligible men were randomly assigned: 319 to sertraline and 311 to placebo. By 12 months, only 204 participants remained engaged with the study. All participants were included in the primary analysis. A primary outcome event (violent offence within 12 months) occurred in 72 (22.6%) of 319 participants assigned sertraline and 70 (22.5%) of 311 assigned placebo (Relative Risk 1.00, 95% CI 0.75-1.34; p = 0.99). Serious adverse events occurred in 22 (6.9%) participants receiving sertraline and 29 (9.3%) receiving placebo. Interpretation: Sertraline did not significantly reduce the risk of violent reoffending compared with placebo. Post-hoc analyses suggested a possible selective effect on domestic violence offending. Funding: Initial funding for the ReINVEST trial was provided from an Australian National Health and Medical Research Council partnership grant No. 533559. From 2018, subsequent funding was provided by the NSW Department of Communities and Justice.