Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000559314
Ethics application status
Approved
Date submitted
26/09/2008
Date registered
7/11/2008
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing impulsive behaviour in repeat violent offenders using a Selective Serotonin Reuptake Inhibitor (Sertraline) - Pilot study.
Scientific title
Reducing impulsive behaviour in repeat violent offenders using a Selective Serotonin Reuptake Inhibitor (Sertraline) - Pilot study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impulsivity
Violence 3759 0
Condition category
Condition code
Mental Health 3940 3940 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Selective Serotonin Reuptake Inhibitor 100mg daily for 3 months.
Intervention code [1] 3473 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4837 0
Impulsive behaviour as measured on the Barratt Impulsiveness Scale.
Timepoint [1] 4837 0
1 month & 3 months
Secondary outcome [1] 8162 0
Depression (Beck Depression Inventory)
Timepoint [1] 8162 0
1 month & 3 months
Secondary outcome [2] 8163 0
Psychological distress (Kessler Psychological distress Scale - K10)
Timepoint [2] 8163 0
1 month & 3 months
Secondary outcome [3] 8164 0
Aggressive behaviour (Anger, Irritability, Aggression Questionnaire - AIAQ)
Timepoint [3] 8164 0
1 month & 3 months

Eligibility
Key inclusion criteria
Men
At least 1 prior conviction for violence
Score over 70 on an impulsivity screener
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current medications include a Selective Serotonin Reuptake Inhibitor (SSRI) or other antidepressant (especially a Mono Amine Oxidase Inhibitor) or anti-psychotics.
Severe mental illness.
History of adverse drug reactions to a Selective Serotonin Reuptake Inhibitor (SSRI).
Past conviction for murder, manslaughter or sexual assault.
Regular use of amphetamine.
From remote/inaccessible area.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
28/02/2009
Date of last data collection
Anticipated
Actual
1/07/2009
Sample size
Target
20
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4126 0
Other
Name [1] 4126 0
NSW Justice Health
Country [1] 4126 0
Australia
Primary sponsor type
Government body
Name
NSW Justice Health
Address
PO Box 150
Matraville NSW 2036
Country
Australia
Secondary sponsor category [1] 3528 0
University
Name [1] 3528 0
National Drug Research Institute
Address [1] 3528 0
PO Box U1987
Perth WA 6845
Country [1] 3528 0
Australia
Secondary sponsor category [2] 3712 0
University
Name [2] 3712 0
National Drug Research Institute
Address [2] 3712 0
PO Box U1987
Perth 6845
Country [2] 3712 0
Australia
Other collaborator category [1] 435 0
Government body
Name [1] 435 0
Hunter New England Health
Address [1] 435 0
Postal Address
PO Box 833, Newcastle
NSW 2300
Country [1] 435 0
Australia
Other collaborator category [2] 469 0
Other
Name [2] 469 0
Hunter New England Health
Address [2] 469 0
PO Box 833, Newcastle
NSW 2300
Country [2] 469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6199 0
NSW Justice Health
Ethics committee address [1] 6199 0
Ethics committee country [1] 6199 0
Australia
Date submitted for ethics approval [1] 6199 0
01/11/2006
Approval date [1] 6199 0
01/12/2006
Ethics approval number [1] 6199 0
GEN59/06

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

Contacts
Principal investigator
Name 28983 0
Address 28983 0
Country 28983 0
Phone 28983 0
Fax 28983 0
Email 28983 0
Contact person for public queries
Name 12140 0
Tony Butler
Address 12140 0
National Drug Research Institute
PO Box U1987
Perth WA 6845
Country 12140 0
Australia
Phone 12140 0
08 9266 1616
Fax 12140 0
08 9266 1611
Email 12140 0
[email protected]
Contact person for scientific queries
Name 3068 0
Tony Butler
Address 3068 0
National Drug Research Institute
PO Box U1987
Perth WA 6845
Country 3068 0
Australia
Phone 3068 0
08 9266 1616
Fax 3068 0
08 9266 1611
Email 3068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No additional documents have been identified.