Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000247673
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
31/08/2005
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Second generation intervention research in the pre-psychotic phase of illness in schizophrenia and related psychoses
Scientific title
Prevention or delay of onset of psychosis in an 'ultra high risk' group: A comparison of risperidone and placebo in combination with intensive psychological treatment
Secondary ID [1] 127 0
RIS-AUS-9
Universal Trial Number (UTN)
Trial acronym
RIS-AUS-9
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia and other psychotic disorders 334 0
Condition category
Condition code
Mental Health 385 385 0 0
Schizophrenia
Mental Health 386 386 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comparison of the effectiveness of low-dose risperidone (0.5-2.0 mg/day) and intensive psychological treatment vs. placebo and intensive psychological treatment vs. placebo and a control psychological treatment in preventing or delaying the onset of psychosis in young people at risk of developing a psychotic illness: A 12-month blinded, placebo-controlled, parallel groups treatment period followed by a 12-month follow-up period.
Intervention code [1] 296 0
None
Comparator / control treatment
Placebo and a control psychological treatment
Control group
Placebo

Outcomes
Primary outcome [1] 443 0
Prevention or delay of onset of psychosis.
Timepoint [1] 443 0
At the end of the 12-month treatment period and the 12-month follow-up period
Secondary outcome [1] 974 0
Improvement in general psychopathology and functioning.
Timepoint [1] 974 0
At the end of 12-month treatment period and the 12-month follow-up period.

Eligibility
Key inclusion criteria
Participants must meet 'ultra high risk' criteria as outlined in Yung, Phillips and McGorry (2004) Treating Schizophrenia in the Prodromal Phase. London: Taylor nd Francis. Also, have not previously experienced psychotic episode, IQ > 70, adequate English skills, and living in Melbourne metro area.
Minimum age
14 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Randomly generated via computer program, medication packaged by automated process, codes stored in locked cabinet and not revealed until trial completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly generated via computer program in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2000
Actual
9/10/2000
Date of last participant enrolment
Anticipated
Actual
15/06/2005
Date of last data collection
Anticipated
Actual
12/04/2006
Sample size
Target
200
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 438 0
Commercial sector/Industry
Name [1] 438 0
Janssen-Cilag Pharmaceuticals
Country [1] 438 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pharmaceuticals
Address
Locked Bag 2070
North Ryde NSW 1670
Country
Australia
Secondary sponsor category [1] 356 0
None
Name [1] 356 0
nil
Address [1] 356 0
Country [1] 356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1411 0
PACE Clinic- Orygen Youth Health, NW Mental Health Program
Ethics committee address [1] 1411 0
Office of Research Ethics & Integrity,
Level 4, 161 Barry St,
The University of Melbourne,
VIC 3010, Australia
Ethics committee country [1] 1411 0
Australia
Date submitted for ethics approval [1] 1411 0
01/06/2000
Approval date [1] 1411 0
30/06/2000
Ethics approval number [1] 1411 0

Summary
Brief summary
To investigate whether risperidone either alone or in combination with an intensive psychological treatment can delay or prevent the onset of an acute psychotic episode in young people thought to be at heightened risk of illness. The secondary aim was to investigate whether the interventions were effective in reducing general pscyhopathology in the participants whilst improving functioning.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 36051 0
Prof Professor Patrick McGorry
Address 36051 0
Orygen Research Centre,
Locked Bag 10,
Parkville VIC 3052, Australia
Country 36051 0
Australia
Phone 36051 0
+61 3 93422800
Fax 36051 0
Email 36051 0
pmcgorry@unimelb.edu.au
Contact person for public queries
Name 9485 0
Dr Dr Barnaby Nelson
Address 9485 0
Personal Assessment Crisis Evaluation (PACE) Clinic
Department of Psychiatry
ORYGEN Research Centre
University of Melbourne
c/- Locked Bag 10
Parkville VIC 3052
Country 9485 0
Australia
Phone 9485 0
+61 3 93176300
Fax 9485 0
+61 3 93170533
Email 9485 0
Barnaby.Nelson@mh.org.au
Contact person for scientific queries
Name 413 0
Prof Prof Patrick McGorry
Address 413 0
Orygen Research Centre
Locked Bag 10
Parkville VIC 3052
Country 413 0
Australia
Phone 413 0
+61 3 93422800
Fax 413 0
+61 3 93422948
Email 413 0
pmcgorry@unimelb.edu.au

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.