Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/07/02

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(s)

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

Study setting(s)

Not specified

Study 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

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

Overall study end date

30/11/2007

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Sex

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

Countries of recruitment

Australia, England, United Kingdom

Study participating centre

Imperial College London
London
W2 1PD
United Kingdom

Organisation

Imperial College London (UK)

Sponsor details

South Kensington Campus
London
SW7 2AZ
England
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

ROR

https://ror.org/041kmwe10

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs