Open, randomised trial of the effect of aripiprazole versus risperidone on social cognition in schizophrenia
| ISRCTN | ISRCTN61441186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61441186 |
| Secondary identifying numbers | NTR405 |
- 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
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aripiprazole, risperidone |
| Primary outcome measure | 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 study start date | 01/12/2005 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Industry
Bristol-Myers Squibb (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Bristol-Myers Squibb Company, BMS
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
