Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability

ISRCTN	ISRCTN11736448
DOI	https://doi.org/10.1186/ISRCTN11736448
Protocol serial number	HTA 01/07/02
Sponsor	Imperial College London (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Three-arm double blind parallel placebo controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	antipsychotic 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.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	30/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	86
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

United Kingdom
England
Australia

Study participating centre

Imperial College London

London
W2 1PD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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