Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability
ISRCTN | ISRCTN11736448 |
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DOI | https://doi.org/10.1186/ISRCTN11736448 |
Secondary identifying numbers | HTA 01/07/02 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 23/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Tyrer
Scientific
Scientific
Imperial College London
Room 4.02
The Paterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom
Phone | +44 (0) 20 7886 1648 |
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p.tyrer@imperial.ac.uk |
Study information
Study design | Three-arm double blind parallel placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | NACHBID |
Study objectives | 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(s) | Not provided at time of registration. |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2002 |
Completion date | 30/11/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 86 patients |
Key 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. |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/08/2002 |
Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
Study participating centre
Imperial College London
London
W2 1PD
United Kingdom
W2 1PD
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
Website | http://www3.imperial.ac.uk/ |
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https://ror.org/041kmwe10 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 05/01/2008 | Yes | No | |
Results article | results | 01/04/2009 | Yes | No |