Open, randomised trial of the effect of aripiprazole versus risperidone on social cognition in schizophrenia
| ISRCTN | ISRCTN61441186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61441186 |
| Protocol serial number | NTR405 |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | Bristol-Myers Squibb (The Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 05/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Rietkerk
Scientific
Scientific
University Medical Centre Utrecht
B.01.206
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 6369 |
|---|---|
| T.Rietkerk@azu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | 80 schizophrenia patients are randomly assigned to either risperidone (4 mg) or aripiprazole (15 mg). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aripiprazole, risperidone |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Lactation 3. Severe head trauma 4. Substance abuse |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
