Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000486628
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting improvement in functional outcomes with aripiprazole
Scientific title
Open label naturalistic six month study of aripiprazole in schizophrenia measuring functional outcomes and positive, negative and cognitive symptoms
Universal Trial Number (UTN)
Trial acronym
Double A Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia and related disorders 608 0
Condition category
Condition code
Mental Health 680 680 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label naturalistic flexible dosing study with aripiprazole for six months.
Intervention code [1] 570 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 822 0
The Assessment of Motor and Process Skills (AMPS: Pan and Fisher, 1994)
Timepoint [1] 822 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [2] 823 0
The World Health Organization Disability Assessment Schedule 2 (WHO-DAS 2: http://www.who.int/icidh/whodas)
Timepoint [2] 823 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [3] 824 0
The PANSS (Positive and Negative Symptom Scale)
Timepoint [3] 824 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [4] 825 0
The RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) list learning task
Timepoint [4] 825 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [5] 826 0
The Penn Face Recognition Test (PFRT)
Timepoint [5] 826 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [6] 827 0
The Penn Emotional Acuity Test (PEAT)
Timepoint [6] 827 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [7] 828 0
The RBANS verbal fluency (semantic)
Timepoint [7] 828 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [8] 829 0
The Wisconsin Card Sort Test (WCST)
Timepoint [8] 829 0
Measured at baseline, 12 weeks and 6 months
Primary outcome [9] 830 0
The Go no-go test
Timepoint [9] 830 0
Measured at baseline, 12 weeks and 6 months
Secondary outcome [1] 1634 0
Simpson-Angus Extrapyramidal Rating Scale
Timepoint [1] 1634 0
Measured at baseline, 12 weeks and six months.
Secondary outcome [2] 1635 0
Calgary Depression Rating Scale
Timepoint [2] 1635 0
Measured at baseline, 12 weeks and six months.

Eligibility
Key inclusion criteria
DSM-IV diagnosis of schizophrenia or related disorder.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
IQ<70; inability to communicate in English language; head injury or neurological disorder; acute drug intoxication.

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 752 0
Charities/Societies/Foundations
Name [1] 752 0
Bristol-Myers Squibb Pharmaceuticals
Country [1] 752 0
Primary sponsor type
Individual
Name
Suresh Sundram
Address
Country
Secondary sponsor category [1] 623 0
Commercial sector/Industry
Name [1] 623 0
Bristol-Myers Squibb Pharmaceuticals
Address [1] 623 0
Country [1] 623 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1973 0
Northern Area Mental Health Service
Ethics committee address [1] 1973 0
Ethics committee country [1] 1973 0
Australia
Date submitted for ethics approval [1] 1973 0
Approval date [1] 1973 0
Ethics approval number [1] 1973 0
Ethics committee name [2] 1974 0
North-Western Area Mental Health Service
Ethics committee address [2] 1974 0
Ethics committee country [2] 1974 0
Australia
Date submitted for ethics approval [2] 1974 0
Approval date [2] 1974 0
Ethics approval number [2] 1974 0

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

Contacts
Principal investigator
Name 36061 0
Address 36061 0
Country 36061 0
Phone 36061 0
Fax 36061 0
Email 36061 0
Contact person for public queries
Name 9759 0
Mr Hamish Molloy
Address 9759 0
Northern Psychiatry Research Centre
185 Cooper Street
Epping Melbourne 3076
Country 9759 0
Australia
Phone 9759 0
+61 3 84058917
Fax 9759 0
+61 3 84058892
Email 9759 0
hamish.molloy@mh.org.au
Contact person for scientific queries
Name 687 0
Suresh Sundram
Address 687 0
Northern Psychiatry Research Centre
185 Cooper Street
Epping Melbourne 3076
Country 687 0
Australia
Phone 687 0
+61 3 84058917
Fax 687 0
+61 3 84058892
Email 687 0
ssundram@mhri.edu.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.