Condition category
Mental and Behavioural Disorders
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
02/04/2008
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 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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes