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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN11736448 |
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Date of registration:
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25/04/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability
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Scientific title:
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Date of first enrolment:
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01/08/2002 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN11736448 |
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Study type:
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Interventional |
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Study design:
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Three-arm double blind parallel placebo controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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Australia
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Peter
Tyrer |
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Address:
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Imperial College London
Room 4.02
The Paterson Centre
20 South Wharf Road
W2 1PD
London
United Kingdom |
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Telephone:
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+44 (0) 20 7886 1648 |
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Email:
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p.tyrer@imperial.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients who have not taken any depot anti-psychotics in the past three months or oral anti-psychotics in the past week but may have received anti-psychotics in the past.
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mental and behavioural disorders: Schizophrenia and other psychoses
Mental and Behavioural Disorders
Schizophrenia
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Intervention(s)
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A three-arm double blind parallel design trial of placebo, haloperidol and risperidone. Block randomisation utilised with even distribution of each drug in every block, thus no gross disparity. Assessments at baseline, four weeks, twelve weeks and six months. All patients have the option of other treatments as usual during this period with the exception of any other anti-psychotic drugs.
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Primary Outcome(s)
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1. Multi-axial Classification - multi-axial classification DSM-IV format with ICD10 codes.
2. Mini PAS-ADD - for psychiatric symptoms.
3. Modified Overt Aggression Scale (MOAS) - for aggressive challenging behaviour (ACB). (primary outcome measure)
4. Aberrant Behaviour Checklist (ABC) - Community - for challenging behaviour (ACB). (secondary outcome measure)
5. Client Service Receipt Inventory (CSRI) - Short version for service costs. (secondary outcome measure)
6. Clinical Global Impressions Scale (CGI) - for illness and global improvement.
7. Uplift/Burden Scale - for burden of care of carers.
8. Quality of Life Questionnaire (QOL-Q) - client quality of life.
9. Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale - includes extra-pyramidal side effects.
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Secondary Outcome(s)
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Not provided at time of registration.
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Secondary ID(s)
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HTA 01/07/02
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Source(s) of Monetary Support
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NIHR Health Technology Assessment Programme - HTA (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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