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Trial registered on ANZCTR
Registration number
ACTRN12605000384651
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
13/09/2005
Date last updated
2/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
CONSTA in Polynesian Subjects
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Scientific title
An observational study of the impact of long-acting risperidone microspheres on the symptom severity and functional recovery in Maori and Pacific people with schizophrenia and related psychotic disorders
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Secondary ID [1]
157
0
RIS-SCH-4050
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Universal Trial Number (UTN)
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Trial acronym
CIPS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
488
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Condition category
Condition code
Mental Health
567
567
0
0
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Schizophrenia
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Risperdal Consta injections as determined by the treating psychiatrist for up to two years.
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Intervention code [1]
335
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None
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
650
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Symptomatic and functional improvement over a one year period
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Assessment method [1]
650
0
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Timepoint [1]
650
0
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Secondary outcome [1]
1345
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Stability of improvement
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Assessment method [1]
1345
0
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Timepoint [1]
1345
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On two year follow up.
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Secondary outcome [2]
1346
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Medication acceptability and side effects
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Assessment method [2]
1346
0
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Timepoint [2]
1346
0
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Eligibility
Key inclusion criteria
Primary disgnosis of schizophreniaUnder care of an ethnic specific service.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unable to give consent.Risperidone prescription contra-indicated.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
9/08/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
160
0
New Zealand
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State/province [1]
160
0
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Funding & Sponsors
Funding source category [1]
618
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Charities/Societies/Foundations
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Name [1]
618
0
Janssen-Cialg Research Fund
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Address [1]
618
0
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Country [1]
618
0
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Primary sponsor type
Commercial sector/Industry
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Name
Janssen-Cilag
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Address
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Country
United Kingdom
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Secondary sponsor category [1]
503
0
None
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Name [1]
503
0
nil
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Address [1]
503
0
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Country [1]
503
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
1734
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Auckland
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Ethics committee address [1]
1734
0
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Ethics committee country [1]
1734
0
New Zealand
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Date submitted for ethics approval [1]
1734
0
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Approval date [1]
1734
0
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Ethics approval number [1]
1734
0
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35600
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Address
35600
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Country
35600
0
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Phone
35600
0
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Fax
35600
0
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Email
35600
0
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Contact person for public queries
Name
9524
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Associate Professor S W Miles
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Address
9524
0
Waitemata District Health Board
Private Bag 93503
Takapuna North Shore City
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Country
9524
0
New Zealand
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Phone
9524
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+64 9 4139734
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Fax
9524
0
+64 9 4487133
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Email
9524
0
[email protected]
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Contact person for scientific queries
Name
452
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Associate Professor S W Miles
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Address
452
0
Waitemata District Health Board
Private Bag 93503
Takapuna North Shore City
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Country
452
0
New Zealand
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Phone
452
0
+64 9 4139734
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Fax
452
0
+64 9 4487133
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Email
452
0
[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Conference abstract
No
Documents added automatically
No additional documents have been identified.
Download to PDF