Contact information
Type
Scientific
Primary contact
Prof Peter Tyrer
ORCID ID
Contact details
Imperial College London
Room 4.02
The Paterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom
+44 (0) 20 7886 1648
p.tyrer@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 01/07/02
Study information
Scientific title
Acronym
NACHBID
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and behavioural disorders: Schizophrenia and other psychoses
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
antipsychotic drugs
Primary outcome measure
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 measures
Not provided at time of registration.
Overall trial start date
01/08/2002
Overall trial end date
30/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
86 patients
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/08/2002
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Australia, United Kingdom
Trial participating centre
Imperial College London
London
W2 1PD
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
South Kensington Campus
London
SW7 2AZ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18177776
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19397849
Publication citations
-
Results
Tyrer P, Oliver-Africano PC, Ahmed Z, Bouras N, Cooray S, Deb S, Murphy D, Hare M, Meade M, Reece B, Kramo K, Bhaumik S, Harley D, Regan A, Thomas D, Rao B, North B, Eliahoo J, Karatela S, Soni A, Crawford M, Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial., Lancet, 2008, 371, 9606, 57-63, doi: 10.1016/S0140-6736(08)60072-0.
-
Results
Tyrer P, Oliver-Africano P, Romeo R, Knapp M, Dickens S, Bouras N, Ahmed Z, Cooray S, Deb S, Murphy D, Hare M, Meade M, Reece B, Kramo K, Bhaumik S, Harley D, Regan A, Thomas D, Rao B, Karatela S, Lenôtre L, Watson J, Soni A, Crawford M, Eliahoo J, North B, Neuroleptics in the treatment of aggressive challenging behaviour for people with intellectual disabilities: a randomised controlled trial (NACHBID)., Health Technol Assess, 2009, 13, 21, iii-iv, ix-xi, 1-54, doi: 10.3310/hta13210.