Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability

ISRCTN ISRCTN11736448
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

Imperial College London
Room 4.02
The Paterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom

Phone +44 (0) 20 7886 1648
Email p.tyrer@imperial.ac.uk

Study information

Study designThree-arm double blind parallel placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymNACHBID
Study objectivesA 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) studiedMental and behavioural disorders: Schizophrenia and other psychoses
InterventionA 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)antipsychotic drugs
Primary outcome measure1. 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 measuresNot provided at time of registration.
Overall study start date01/08/2002
Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants86 patients
Key inclusion criteriaPatients 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/08/2002
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • Australia
  • England
  • United Kingdom

Study participating centre

Imperial College London
London
W2 1PD
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

South Kensington Campus
London
SW7 2AZ
England
United Kingdom

Website http://www3.imperial.ac.uk/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/01/2008 Yes No
Results article results 01/04/2009 Yes No