|
ISRCTN
|
ISRCTN11736448
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability
|
|
Scientific title
|
|
|
Acronym
|
NACHBID
|
|
Serial number at source
|
HTA 01/07/02
|
|
Study hypothesis
|
A multi-centre randomised controlled trial to recruit sufficient learning disability patients to test the null hypotheses that:
1. Compared to placebo antipsychotic drugs do not reduce the incidence of aggressive behaviour in those with learning disability and challenging behaviour.
2. There is no difference between the cost-effectiveness of prescribing risperidone, haloperidol or placebo in those with aggressive challenging behaviour.
More details can be found at: http://www.hta.ac.uk/1322
Protocol can be found at: http://www.hta.ac.uk/protocols/200100070002.pdf
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Three-arm double blind parallel placebo controlled trial
|
|
Countries of recruitment
|
United Kingdom, Australia
|
|
Disease/condition/study domain
|
Mental and behavioural disorders: Schizophrenia and other psychoses
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
Does not meet inclusion criteria
|
|
Anticipated start date
|
01/08/2002
|
|
Anticipated end date
|
30/11/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
86 patients
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
|
|
Publications
|
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18177776
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19397849
|
|
Contact name
|
Prof
Peter
Tyrer
|
|
Address
|
Imperial College London
Room 4.02
The Paterson Centre
20 South Wharf Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
W2 1PD
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7886 1648
|
|
Fax
|
+44 (0) 20 7886 1994/5
|
|
Email
|
p.tyrer@imperial.ac.uk
|
|
Sponsor
|
Imperial College London (UK)
|
|
Address
|
South Kensington Campus
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW7 2AZ
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www3.imperial.ac.uk/
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
23/07/2009
|
|
Date ISRCTN assigned
|
25/04/2003
|
