Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000202662
Ethics application status
Approved
Date submitted
12/08/2005
Date registered
23/08/2005
Date last updated
13/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of cognitive remediation in psychosis
Scientific title
A randomised controlled trial of cognitive remediation in the treatment of cognitive deficits in schizophrenia
Secondary ID [1] 262365 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 283 0
Condition category
Condition code
Mental Health 320 320 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computer assisted cognitive remediation
immediate treatment
Intervention code [1] 178 0
Treatment: Other
Comparator / control treatment
A wait-list control
Control group
Historical

Outcomes
Primary outcome [1] 374 0
Improvement in cognitive deficits
Timepoint [1] 374 0
At the end of treatment and at 15 weeks post treatment
Secondary outcome [1] 833 0
Improvement in negative symptoms
Timepoint [1] 833 0
At end of treatment and at 15 weeks post treatment.
Secondary outcome [2] 834 0
Quality of life
Timepoint [2] 834 0
At end of treatment and at 15 weeks post treatment.
Secondary outcome [3] 835 0
Social function and self esteem
Timepoint [3] 835 0
At end of treatment and at 15 weeks post treatment.

Eligibility
Key inclusion criteria
Diagnosis of schizophrenia, cognitive deficit of > 1 SD below premorbid functioning, stable medication for 2 months, stable residence.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mental retardation, non-english speaking, current substance abuse, significant head injury or neurological condition, ECT in past 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was by coin toss at time of randomisation therefore allocation concealment was not required
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 375 0
Commercial sector/Industry
Name [1] 375 0
Eli Lilly Australia
Country [1] 375 0
Australia
Funding source category [2] 376 0
Charities/Societies/Foundations
Name [2] 376 0
Perpetual Trustees
Country [2] 376 0
Australia
Funding source category [3] 377 0
Charities/Societies/Foundations
Name [3] 377 0
Schizophrenia Fellowship of NSW Research Trust Fund
Country [3] 377 0
Australia
Primary sponsor type
Individual
Name
Dr Anthony Harris
Address
Department of Psychiatry Westmead Hospital Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 302 0
None
Name [1] 302 0
Address [1] 302 0
Country [1] 302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1364 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 1364 0
Ethics committee country [1] 1364 0
Australia
Date submitted for ethics approval [1] 1364 0
Approval date [1] 1364 0
Ethics approval number [1] 1364 0
Ethics committee name [2] 1365 0
Western Sydney and Wentworth AHS
Ethics committee address [2] 1365 0
Ethics committee country [2] 1365 0
Australia
Date submitted for ethics approval [2] 1365 0
Approval date [2] 1365 0
Ethics approval number [2] 1365 0
Ethics committee name [3] 1366 0
Northern Sydney AHS Human Research Ethics Committee
Ethics committee address [3] 1366 0
Ethics committee country [3] 1366 0
Australia
Date submitted for ethics approval [3] 1366 0
Approval date [3] 1366 0
Ethics approval number [3] 1366 0

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

Contacts
Principal investigator
Name 36231 0
Address 36231 0
Country 36231 0
Phone 36231 0
Fax 36231 0
Email 36231 0
Contact person for public queries
Name 9367 0
Dr Anthony Harris
Address 9367 0
Department of Psychiatry Westmead Hospital Westmead NSW 2145
Country 9367 0
Australia
Phone 9367 0
+61 2 98456688
Fax 9367 0
+61 2 96357734
Email 9367 0
aharris1@mail.usyd.edu.au
Contact person for scientific queries
Name 295 0
Dr Anthony Harris
Address 295 0
Department of Psychiatry
Westmead Hospital
Westmead NSW 2145
Country 295 0
Australia
Phone 295 0
+61 2 98456688
Fax 295 0
+61 2 96357734
Email 295 0
aharris1@mail.usyd.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23115Informed consent form  anthony.harris@sydney.edu.au Please email
23116Clinical study reportAvailable at Schizophrenia Bulletin or email the author below anthony.harris@sydney.edu.au
23117Ethical approval  anthony.harris@sydney.edu.au Acknowledgement of ethical approval is in the orig... [More Details]

Results publications and other study-related documents

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

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Randomized Controlled Trial of Cognitive Remediation in Schizophrenia2008https://doi.org/10.1093/schbul/sbn102
N.B. These documents automatically identified may not have been verified by the study sponsor.