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
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