Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000556640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
29/09/2005
Date last updated
17/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Seroquel compared to Risperidone in the treatment of psychotic disorders adolescents.
Scientific title
Randomised controlled clinical trial of the efficacy and tolerability of Seroquel compared to Risperidone in the treatment of psychotic disorders among 15-18 year old adolescents.
Secondary ID [1] 181 0
D1441C00019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent psychosis 681 0
Condition category
Condition code
Mental Health 756 756 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Quetiapine fumarate (titrate to between 400 and 800mg)

Risperidone (titrated to between 4-6mg)
Intervention code [1] 547 0
None
Comparator / control treatment
Risperidone is the comparator. Orally administered for a period of six weeks at a dose not exceeding 6 mg titrated according to clinical response.
Control group
Active

Outcomes
Primary outcome [1] 944 0
BPRS
Timepoint [1] 944 0
On Days 2, 21, and 42
Primary outcome [2] 945 0
PANS
Timepoint [2] 945 0
On Days 2, 21, and 42
Primary outcome [3] 946 0
CGI
Timepoint [3] 946 0
On Days 2, 21, and 42
Primary outcome [4] 947 0
CGI-S Hamilton RSD
Timepoint [4] 947 0
On Days 2, 21, and 42
Primary outcome [5] 948 0
Becks Depression Inventory
Timepoint [5] 948 0
On Days 2, 21, and 42
Primary outcome [6] 949 0
Glodberg Mania Questionaire
Timepoint [6] 949 0
On Days 2, 21, and 42
Secondary outcome [1] 1806 0
Abnormal Involuntary Movements Scale
Timepoint [1] 1806 0
On days 2, 6, 10, 17, 21, 28, 35, 42.
Secondary outcome [2] 1807 0
Angus Simpson Scale
Timepoint [2] 1807 0
On days 2, 6, 10, 17, 21, 28, 35, 42.
Secondary outcome [3] 1808 0
Liver Function Tests
Timepoint [3] 1808 0
On Days 2 and 42.
Secondary outcome [4] 1809 0
Haematology
Timepoint [4] 1809 0
On Days 2 and 42.
Secondary outcome [5] 1810 0
Renal Function Tests
Timepoint [5] 1810 0
On Days 2 and 42.
Secondary outcome [6] 1811 0
Thyroid Function Tests
Timepoint [6] 1811 0
On Days 2 and 42.
Secondary outcome [7] 1812 0
Serum Prolactin
Timepoint [7] 1812 0
On Days 2 and 42.
Secondary outcome [8] 1813 0
Fasting blood glucose
Timepoint [8] 1813 0
On Days 2 and 42.

Eligibility
Key inclusion criteria
Provision of written informed consent. Young people under the age of 19 years admitted to the Youth Inpatient Unit YIU) with a psychotic disorder according to DSM-IV criteria.Subjects must have a chronic or intermittent psychosis with a documented clinical diagnosis of: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Major Depressive Disorder with psychotic features, or Bipolar I Disorder according to the criteria of DSM IV [18].
Minimum age
Not stated
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with alcohol or substance dependence not in full remission. Previous and successful treatment with Quetiapine or Risperidone.History of non-response to atypicals.Patients who have taken Clozapine within the previous 60 days.A positive test for pregnancy.Sexually active females who are not on a medically validated contraceptive e.g. double barrier, oral contraceptives, DepoProvera.Any clinical significant medical condition that could affect required evaluation or increase the risk of adverse affects with treatment.

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)
Open Label Study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are alternately allocated to either quetiapine or risperidone
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 213 0
New Zealand
State/province [1] 213 0

Funding & Sponsors
Funding source category [1] 837 0
Commercial sector/Industry
Name [1] 837 0
AstraZeneca
Country [1] 837 0
Australia
Primary sponsor type
Individual
Name
Dr Harith Swadi
Address
Princess Margaret Hospital
Christchurch
Country
New Zealand
Secondary sponsor category [1] 704 0
None
Name [1] 704 0
NA
Address [1] 704 0
Country [1] 704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2099 0
Princess Margaret Hospital
Ethics committee address [1] 2099 0
Ethics committee country [1] 2099 0
New Zealand
Date submitted for ethics approval [1] 2099 0
Approval date [1] 2099 0
Ethics approval number [1] 2099 0

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

Contacts
Principal investigator
Name 35233 0
Address 35233 0
Country 35233 0
Phone 35233 0
Fax 35233 0
Email 35233 0
Contact person for public queries
Name 9736 0
Dr Harith Swadi
Address 9736 0
Consultant Psychiatrist
Youth Inpatient Unit
Princess Margaret Hospital
PO Box 800
Christchurch
Country 9736 0
New Zealand
Phone 9736 0
+64 3 3377800
Fax 9736 0
Email 9736 0
harith.swadi@cdhb.govt.nz
Contact person for scientific queries
Name 664 0
Dr Harith Swadi
Address 664 0
Consultant Psychiatrist
Youth Inpatient Unit
Princess Margaret Hospital
PO Box 800
Christchurch
Country 664 0
New Zealand
Phone 664 0
+64 3 3377800
Fax 664 0
Email 664 0
harith.swadi@cdhb.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.