Condition category
Mental and Behavioural Disorders
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
05/11/2008
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 Thomas Rietkerk

ORCID ID

Contact details

University Medical Centre Utrecht
B.01.206
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 6369
T.Rietkerk@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR405

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise that, because of its unique action as a partial dopamine agonist in brain circuits underlying social cognition, treatment with aripiprazole will lead to a significant improvement in social cognitive processing compared to risperidone.

Ethics approval

Not provided at time of registration

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia

Intervention

80 schizophrenia patients are randomly assigned to either risperidone (4 mg) or aripiprazole (15 mg).

Intervention type

Drug

Phase

Not Specified

Drug names

Aripiprazole, risperidone

Primary outcome measures

The effect of treatment with risperidone or aripiprazole on social cognitive processes in patients with schizophrenia is the primary result of this study. These processes are assessed using computerised cognitive tasks. The objective of the study is to determine which of the two antipsychotics is the most effective against social cognitive deficits.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) based diagnosis of schizophrenia
2. Aged 18 - 50 years
3. Active contraception
4. Intelligence quotient (IQ) greater than 80
5. Negative pregnancy test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Pregnancy
2. Lactation
3. Severe head trauma
4. Substance abuse

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl

Funders

Funder type

Industry

Funder name

Bristol-Myers Squibb (The Netherlands)

Alternative name(s)

Bristol-Myers Squibb Company, BMS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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

Publication citations

Additional files

Editorial Notes