Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/11/2009
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

Dr Peter J McKenna

ORCID ID

Contact details

Box No 316
The Yews
Fulbourn Hospital
Cambridge
CB1 5EY
United Kingdom
+44 (0)1223 218814
peter.mckenna@virgin.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00272584

Protocol/serial number

N0544099315

Study information

Scientific title

Acronym

Study hypothesis

Background: Clozapine represents a significant advance in the treatment of the most severely ill patients with schizophrenia. However, a subgroup continues to be psychotic and disabled even with adequate clozapine treatment. A trial of risperidone augmentation of clozapine is proposed. This strategy is based on the rationale that risperidone has some documented efficacy as monotherapy in severely ill patients, and may have a somewhat different profile of effects on cognition compared to clozapine.

Hypothesis: Risperidone augmentation will reduce symptoms and improve working memory compared to placebo augmentation.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia

Intervention

A double-blind, randomised controlled trial of risperidone compared to placebo augmentation will be carried out with 100 subjects. All subjects will continue on clozapine therapy. Symptomatic, functional, side effects and neurocognitive assessments will be carried out at 4, 8 and 26 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

clozapine, risperidone

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/03/2001

Overall trial end date

20/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

100 Subjects (PROJ 16/10/2000)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

20/03/2001

Recruitment end date

20/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 316
Cambridge
CB1 5EY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Other

Funder name

Cambridge Consortium - Addenbrookes (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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16452559

Publication citations

  1. Results

    Honer WG, Thornton AE, Chen EY, Chan RC, Wong JO, Bergmann A, Falkai P, Pomarol-Clotet E, McKenna PJ, Stip E, Williams R, MacEwan GW, Wasan K, Procyshyn R, , Clozapine alone versus clozapine and risperidone with refractory schizophrenia., N. Engl. J. Med., 2006, 354, 5, 472-482, doi: 10.1056/NEJMoa053222.

Additional files

Editorial Notes