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Trial registered on ANZCTR


Registration number
ACTRN12613000442707
Ethics application status
Approved
Date submitted
16/04/2013
Date registered
18/04/2013
Date last updated
21/01/2022
Date data sharing statement initially provided
13/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing impulsivity in repeat violent offenders using a selective serotonin reuptake inhibitor (sertraline)
Scientific title
Reducing impulsivity in repeat violent offenders using a selective serotonin reuptake inhibitor (sertraline)
Secondary ID [1] 282344 0
none
Universal Trial Number (UTN)
U1111-1141-9617
Trial acronym
ReINVEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Offending behaviour 288894 0
Impulsivity 288898 0
Anger 288899 0
Aggression 288902 0
Condition category
Condition code
Other 289240 289240 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.



Intervention code [1] 286962 0
Behaviour
Intervention code [2] 286963 0
Lifestyle
Comparator / control treatment
Placebo will contain the inactive ingredients of setrona: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycollate, hydroxypropyl cellulose, magnesium stearate, white Opadry, hypromellose, titanium dioxide, macrogol 400, purified talc. The placebo tablets will be identical in shape, colour and levry to the Setrona. The dosing will be the same as the active and as an oral tablet.
Control group
Placebo

Outcomes
Primary outcome [1] 289359 0
Offending behaviour.

Re-offending will be determined by linking the participant list to the NSW Bureau of Crime Statistics Reoffending Database (ROD) which records individuals' criminal court appearances over time.
Timepoint [1] 289359 0
Assessed retrospectively at 12 months following commencement of the intervention or control treatment.
Secondary outcome [1] 302303 0
Impulsivity
Timepoint [1] 302303 0
Impulsivity is assessed using the Barratt Impulsiveness Scale at Randomisation (Week 0), Week 2, Week 6, and then every 8 weeks after that.
Secondary outcome [2] 302352 0
Anger
Timepoint [2] 302352 0
Anger is assessed using the State Trait Anger Expression Inventory at Week 2, Week 6 and then every 16 weeks after that. Anger is also assessed using the Anger, Irritability and Aggression questionnaire at Randomisation (Week 0), Week 2, Week 6, and then every 16 weeks after that.
Secondary outcome [3] 302355 0
Depression
Timepoint [3] 302355 0
Depression is assessed using the Beck Depression Inventory at Randomisation (Week 0), Week 2, Week 6, Week 14 and Week 30.
Secondary outcome [4] 302357 0
Irritability
Timepoint [4] 302357 0
Irritability is assessed using the Anger, Irritability and Aggression questionnaire at Randomisation (Week 0), Week 2, Week 6, and then every 16 weeks after that.
Secondary outcome [5] 405188 0
Quality of life
Timepoint [5] 405188 0
Quality of life is assessed using the Short-Form-12 at Week 2, Week 6, and then every 16 weeks after that.
Secondary outcome [6] 405189 0
Social functioning
Timepoint [6] 405189 0
Social functioning is assessed using the Duke Social Support Scale at Randomisation (Week 0), Week 28 and Week 38.
Secondary outcome [7] 405190 0
Psychological distress
Timepoint [7] 405190 0
Psychological distress is assessed using the Kessler Psychological Distress Scale at Randomisation (Week 0), Week 2, Week 6, and every 8 weeks after that.
Secondary outcome [8] 405191 0
Substance use and alcohol consumption
Timepoint [8] 405191 0
Substance use and alcohol consumption is assessed at Randomisation (Week 0), Week 2, Week 6, and then every 8 weeks after that. Questions derived from the 2001 New South Wales Inmate Health Survey.
Secondary outcome [9] 405192 0
Self-reported offending
Timepoint [9] 405192 0
Self-reported offending is assessed by enquiring about whether a criminal act or offence has been committed in the past eight weeks, and if so, details about the offence(s). This is assessed at Randomisation (Week 0), Week 2, Week 6, and then every 8 weeks after that.
Secondary outcome [10] 405193 0
Aggression
Timepoint [10] 405193 0
Aggression is assessed using the Anger, Irritability and Aggression questionnaire at Randomisation (Week 0), Week 2, Week 6, and then every 16 weeks after that.
Secondary outcome [11] 405194 0
Effect of polymorphisms in the serotonin transporter gene 5HTTLPR on the efficacy of SSRIs
Timepoint [11] 405194 0
In those prescribed SSRI (i.e. the treatment arm of the study) changes in impulsivity and depression from baseline to 12 months will be compared between those with s/s versus l/s or l/l alleles using a repeated measures analysis. Genetic samples are collected at the run-in appointment. Impulsivity is assessed using the Barratt Impulsiveness Scale at Randomisation (Week 0), Week 2, Week 6, and then every 8 weeks after that. Depression is assessed using the Beck Depression Inventory at Randomisation (Week 0), Week 2, Week 6, Week 14 and Week 30.

Eligibility
Key inclusion criteria
Male sex;
Over the age of 18 years;
Prior conviction for 2 or more violent offences;
Score of 70 or above on the Barratt Impulsiveness Scale;
Medically fit to undertake the trial;
Able to provide informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current use of any serotonergic drug (e.g. SSRI, SNRI, TCA);
History of adverse drug reactions to SSRI;
Current use of any anti-psychotic medication;
Severe mental illness
Considered to be at high risk of suicide;
Anticipation of receiving a custodial sentence;
Significant renal or hepatic impairment;
Inability to provide informed consent;
Conviction for murder or child sexual assault;
Impending deportation, moving interstate, returning to a remote/inaccessible area.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will also be recruited from those serving community orders under the aegis of Corrective Services NSW, Community Offender Management at sites in the Sydney metropolitan and outer metropolitan areas. A targeted approach will be used whereby Corrective Services NSW will provide a list of those potentially eligible for the study (e.g. male, over 18, two or more convictions for violence). Those who express an interest in the study will receive a follow-up visit from a research nurses. At this meeting they will be provided with a full explanation of the study and the inclusion/exclusion criteria will be examined. Those who express an interest in the study and meet the basic inclusion criteria will be invited for a medical assessment to determine medical suitability for the trial prior to commencement.

Randomisation will occur centrally by the NHMRC Clinical Trials Centre (Sydney University) and forwarded to the pharmacy for distribution of the medication.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using computer generated random blocks to ensure that in every block 50% of subjects are randomised to active and 50% to placebo. Similarly, the Level of Service Inventory instrument will be used to ensure that those at 'medium' to 'high' risk of reoffending are evenly allocated to the two arms of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The expected rate of first violent or impulsive re-offence in the control group is expected to be approximately 33% at 12 months, and a minimum of 12% reduction in this rate using sertraline would be considered sufficient to be clinically meaningful and have an impact on practice in this area. A sample size of 460 patients (230 in each group) would provide 80% power with 95% confidence to detect this difference. While these estimates are conservative, if the control rate was 37%, the study would still have 80% power to detect a 12% absolute reduction. As mentioned above, the re-offending rates will be monitored to ensure that the sample size will provide sufficient power to detect meaningful differences. This will also include an assessment of the non-compliance and crossover rates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
21/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
180
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287102 0
Government body
Name [1] 287102 0
NHMRC
Country [1] 287102 0
Australia
Funding source category [2] 307189 0
Government body
Name [2] 307189 0
NSW Department of Communities and Justice
Country [2] 307189 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
Human Research and Ethics Committee
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 285880 0
Other
Name [1] 285880 0
Corrective Services NSW
Address [1] 285880 0
Henry Deane Building
20 Lee Street
Sydney NSW 2000
Country [1] 285880 0
Australia
Secondary sponsor category [2] 285881 0
Other
Name [2] 285881 0
Hunter New England Health
Address [2] 285881 0
Locked Bag 1
New Lambton NSW 2305
Australia
Country [2] 285881 0
Australia
Secondary sponsor category [3] 285882 0
Other
Name [3] 285882 0
Bureau of Crime Statistics and Research
Address [3] 285882 0
NSW Bureau of Crime Statistics and Research
GPO Box 6
SYDNEY NSW 2001
AUSTRALIA
Country [3] 285882 0
Australia
Secondary sponsor category [4] 285883 0
University
Name [4] 285883 0
NHMRC Clinical Trials Centre
Address [4] 285883 0
NHMRC Clinical Trials Centre
ABN 15 211 513 464
Locked Bag 77
Camperdown NSW 1450
Country [4] 285883 0
Australia
Other collaborator category [1] 277358 0
Other
Name [1] 277358 0
Justice & Forensic Mental Health Network
Address [1] 277358 0
PO Box 150
MATRAVILLE NSW 2036
Australia
Country [1] 277358 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289116 0
University of NSW
Ethics committee address [1] 289116 0
Ethics committee country [1] 289116 0
Australia
Date submitted for ethics approval [1] 289116 0
Approval date [1] 289116 0
12/10/2011
Ethics approval number [1] 289116 0
HC11390, HC17771
Ethics committee name [2] 289117 0
Aboriginal Health and Medical Research Council
Ethics committee address [2] 289117 0
Ethics committee country [2] 289117 0
Australia
Date submitted for ethics approval [2] 289117 0
Approval date [2] 289117 0
14/05/2012
Ethics approval number [2] 289117 0
822/11
Ethics committee name [3] 289118 0
Corrective Services NSW
Ethics committee address [3] 289118 0
Ethics committee country [3] 289118 0
Australia
Date submitted for ethics approval [3] 289118 0
Approval date [3] 289118 0
24/07/2012
Ethics approval number [3] 289118 0
09/26576
Ethics committee name [4] 310207 0
Justice Health and Forensic Mental Health Network
Ethics committee address [4] 310207 0
Ethics committee country [4] 310207 0
Australia
Date submitted for ethics approval [4] 310207 0
12/09/2013
Approval date [4] 310207 0
29/05/2014
Ethics approval number [4] 310207 0
G8/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39322 0
Prof tony butler
Address 39322 0
Justice Health Research Program, School of Population Health, Level 2, Samuels Building, UNSW Sydney, NSW 2052
Country 39322 0
Australia
Phone 39322 0
+61 2 9385 9257
Fax 39322 0
+61 2 9385 0891
Email 39322 0
tbutler@unsw.edu.au
Contact person for public queries
Name 39323 0
tony butler
Address 39323 0
Justice Health Research Program, School of Population Health, Level 2, Samuels Building, UNSW Sydney, NSW 2052
Country 39323 0
Australia
Phone 39323 0
+61 2 9385 9257
Fax 39323 0
+61 2 9385 0891
Email 39323 0
tbutler@unsw.edu.au
Contact person for scientific queries
Name 39324 0
tony butler
Address 39324 0
Justice Health Research Program, School of Population Health, Level 2, Samuels Building, UNSW Sydney, NSW 2052
Country 39324 0
Australia
Phone 39324 0
+61 2 9385 9257
Fax 39324 0
+61 2 9385 0891
Email 39324 0
tbutler@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): Protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial.2021https://dx.doi.org/10.1136/bmjopen-2020-044656
N.B. These documents automatically identified may not have been verified by the study sponsor.