Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000394640
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Schizophrenia with Aripiprazole. A one year open-label study.
Scientific title
Treatment of Schizophrenia with Aripiprazole. A one year open-label study examining an ultraslow switchover regime to minimise relapse and withdrawal symptoms.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 498 0
Condition category
Condition code
Mental Health 578 578 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Switchover from current antipsychotic to Aripiprazole.
Intervention code [1] 377 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 671 0
The primary objective is to use a clinical procedure of a minimum of 12 weeks, to gradually changeover from the patients current antipsychotic to a new antipsychotic agent known as Aripiprazole (Abilify). The hypothesis for this study is that relapse of psychosis and withdrawal symptoms will be minimised by the longer changeover period and it will improve patients tolerability of Aripiprazole and therefore, compliance.
Timepoint [1] 671 0
Assessments will be done monthly and the full effects of the primary outcome will be measured after one year.
Secondary outcome [1] 1378 0
The secondary objective is to systematically collect data, as generated by various scientific tools (Rating Scales) and subjective experiences of patients.
Timepoint [1] 1378 0
At monthly intervals for 12 months. Pathology and ECG tests will be done at Baseline, 3 months and 12 months.

Eligibility
Key inclusion criteria
Patients who are outpatients (private or public) attending southern health facility and have a well established diagnosis of schizophrenia (DSM-IV diagnosis criteria), who report side effects on their existing medication, who have not fully responded to their current therapy, who in the clinicians opinion, would benefit from Aripiprazole, who are able to comprehend what is happening to them and able to give informed consent, who can speak a reasonable level of English, and where completing rating scales with adequate information is not a practical problem.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who want to become pregnant during the study period, with alcohol dependence, with acquired brain injury associated with schizophrenia, who are on too complex medication regimes which would be difficult to change, who have previously been treated with Aripiprazole, who are on very high doses of clozapine in (>500mg/day), on very high doses of injectable Zuclopenthixol Decanoate (>200mg/fortnight), with a past history of severe violence/suicidal risk, who are generally non-compliant with oral medication, who have poor social supports and are very unreliable with appointments, and patients who are very stable on their current antipsychotic medication, but want to change to Aripiprazole simply because it is a new drug, their friend got better or, someone told them it is a good idea.

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
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 628 0
Commercial sector/Industry
Name [1] 628 0
Bristol-Myers Squib Pharmaceuticals
Country [1] 628 0
Primary sponsor type
Individual
Name
Associate Professor Krishna Vaddadi
Address
Country
Secondary sponsor category [1] 513 0
Individual
Name [1] 513 0
Dr Athula Polonowita
Address [1] 513 0
Country [1] 513 0
Secondary sponsor category [2] 514 0
Individual
Name [2] 514 0
Dr Kamal Sanghvi
Address [2] 514 0
Country [2] 514 0
Secondary sponsor category [3] 515 0
Individual
Name [3] 515 0
Dr Naomi Elliot
Address [3] 515 0
Country [3] 515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1761 0
Monash University
Ethics committee address [1] 1761 0
Ethics committee country [1] 1761 0
Australia
Date submitted for ethics approval [1] 1761 0
Approval date [1] 1761 0
Ethics approval number [1] 1761 0
Ethics committee name [2] 1762 0
Southern Health Human Research Ethics Committees
Ethics committee address [2] 1762 0
Ethics committee country [2] 1762 0
Australia
Date submitted for ethics approval [2] 1762 0
Approval date [2] 1762 0
Ethics approval number [2] 1762 0

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

Contacts
Principal investigator
Name 35835 0
Address 35835 0
Country 35835 0
Phone 35835 0
Fax 35835 0
Email 35835 0
Contact person for public queries
Name 9566 0
Ms Belinda Kelly
Address 9566 0
Department of Psychological Medicine
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 9566 0
Australia
Phone 9566 0
+61 3 85416314
Fax 9566 0
+61 3 85416311
Email 9566 0
Belinda.Kelly@southernhealth.org.au
Contact person for scientific queries
Name 494 0
Associate Professor Krishna Vaddadi
Address 494 0
Department of Psychological Medicine
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 494 0
Australia
Phone 494 0
+61 3 85416314
Fax 494 0
+61 3 85416311
Email 494 0
Krishna.Vaddadi@southernhealth.org.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.