Contact information
Type
Scientific
Primary contact
Dr Lonneke van Nimwegen
ORCID ID
Contact details
Academic Medical Centre
University of Amsterdam
Adolescent Clinic
Department of Psychiatry
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands
+31 (0)20 566 2142
L.J.vanNimwegen@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR28
Study information
Scientific title
Acronym
SUB.CAN.OLA.RIS
Study hypothesis
Not provided at time of registration
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, double-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia, schizo-affective disorder, schizofreniform disorder
Intervention
Patients are treated double blind with olanzapine (5 - 20 mg) or risperidone (1.25 - 5 mg) for six weeks. At t = 0, t = 7 days and t = 42 days, questionnaires are taken and after six weeks the medication is disclosed. The physician and patient decide if this neuroleptic will be continued. After one year the questionnaires are taken once more.
Intervention type
Drug
Phase
Not Specified
Drug names
Olanzapine and risperidone
Primary outcome measures
1. Subjective Well-Being Under Neuroleptics Scale (SWN)
2. Obsessive Compulsive Drug Use Scale (OCDUS)
3. Positive And Negative Symptoms Scale (PANSS) based on information from the semi-structured interview (SCI-PANSS)
4. Calgary Depression Rating Scale (CDRS)
5. Extra-Pyramidal Symptom Rating Scale (ESRS)
6. Clinical Global Impression (CGI)
7. Yale Brown Obsessive Compulsive Scale (Y-BOCS)
8. Desires for Drugs Questionnaire (DDQ)
9. Drug Use Self Report (DUSR)
10. Recent Drug Use Urinalysis (RDUU)
Secondary outcome measures
1. Drop out from the study
2. Medication compliance and medication switch, symptoms and rehospitalisations during one year follow up, measured with the Life Chart Schedule (LCS)
Overall trial start date
01/07/2003
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients should be able to understand the study description and give informed consent
2. Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
3. Patients experience a first or second psychotic episode
4. Age is between 18 and 30 years
5. No current use of clozapine
6. Patients must be reliable. They must agree to co-operate with all tests and examinations required by the protocol
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Pregnancy
2. Lactating women
3. Female subject without adequate contraception
4. Known hypersensitivity to any ingredient of olanzapine or risperidone
5. Concomitant use of any other antipsychotic drug than olanzapine or risiperidone
6. Patients are not allowed to have received depot anti-psychotics for a period of at least three months prior to the study
7. Use of other psychotropic medication other than oxazepam or biperiden
8. Narrow-angle glaucoma
9. Known neurological or endocrine disease
Recruitment start date
01/07/2003
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 BC
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Psychiatry
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Eli Lilly (The Netherlands)
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