Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 157 0
RIS-SCH-4050
Universal Trial Number (UTN)
Trial acronym
CIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 488 0
Condition category
Condition code
Mental Health 567 567 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Risperdal Consta injections as determined by the treating psychiatrist for up to two years.
Intervention code [1] 335 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 650 0
Symptomatic and functional improvement over a one year period
Timepoint [1] 650 0
Secondary outcome [1] 1345 0
Stability of improvement
Timepoint [1] 1345 0
On two year follow up.
Secondary outcome [2] 1346 0
Medication acceptability and side effects
Timepoint [2] 1346 0

Eligibility
Key inclusion criteria
Primary disgnosis of schizophreniaUnder care of an ethnic specific service.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give consent.Risperidone prescription contra-indicated.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 160 0
New Zealand
State/province [1] 160 0

Funding & Sponsors
Funding source category [1] 618 0
Charities/Societies/Foundations
Name [1] 618 0
Janssen-Cialg Research Fund
Country [1] 618 0
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag
Address
Country
United Kingdom
Secondary sponsor category [1] 503 0
None
Name [1] 503 0
nil
Address [1] 503 0
Country [1] 503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1734 0
Auckland
Ethics committee address [1] 1734 0
Ethics committee country [1] 1734 0
New Zealand
Date submitted for ethics approval [1] 1734 0
Approval date [1] 1734 0
Ethics approval number [1] 1734 0

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

Contacts
Principal investigator
Name 35600 0
Address 35600 0
Country 35600 0
Phone 35600 0
Fax 35600 0
Email 35600 0
Contact person for public queries
Name 9524 0
Associate Professor S W Miles
Address 9524 0
Waitemata District Health Board
Private Bag 93503
Takapuna North Shore City
Country 9524 0
New Zealand
Phone 9524 0
+64 9 4139734
Fax 9524 0
+64 9 4487133
Email 9524 0
wayne.miles@waitematadhb.govt.nz
Contact person for scientific queries
Name 452 0
Associate Professor S W Miles
Address 452 0
Waitemata District Health Board
Private Bag 93503
Takapuna North Shore City
Country 452 0
New Zealand
Phone 452 0
+64 9 4139734
Fax 452 0
+64 9 4487133
Email 452 0
wayne.miles@waitematadhb.govt.nz

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo

Documents added automatically
No additional documents have been identified.