Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
23/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes