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Subjective well-being, craving for cannabis and compliance or medication switch in a randomized doubleblind study with olanzapine and risperidone.


- candidate number0
- NTR NumberNTR28
- ISRCTNISRCTN46365995
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR22-nov-2004
- Secondary IDsN/A 
- Public TitleSubjective well-being, craving for cannabis and compliance or medication switch in a randomized doubleblind study with olanzapine and risperidone.
- Scientific TitleSubjective well-being, craving for cannabis and compliance or medication switch in a randomized doubleblind study with olanzapine and risperidone.
- ACRONYMSUB.CAN.OLA.RIS
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedSchizophrenia
- Inclusion criteria1. Patients should be able to understand the study description and give informed consent;
2. Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to 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.
- Exclusion criteria1. Pregnancy;
2. Lactating women;
3. Female subject without adequate contraconception;
4. Known hypersensitivity to any ingredient of olanzapine or risperidone;
5. Concomitant use of any other antipsychotic drug than olanzapine or rsiperidone;
6. Patients are not allowed to have received depot- antipsychotics for a period of at least 3 months prior to the study;
7. Use of other psychotropic medication other than oxazepam or biperideen;
8. Narrow-angle glaucoma;
9. Known neurological or endocrine disease.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2003
- planned closingdate1-jul-2007
- Target number of participants120
- InterventionsPatients are treated double blind with olanzapine (5-20 mg) or risperidone (1,25-5 mg) for 6 weeks. At t=0, t=7 days and t=42 days, questionnaires are taken and after 6 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.
- Primary outcome1. 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. ESRS: Extra pyramidal Symptom Rating Scale;
6. Clinical Global Impression (CGI);
7. Y-BOCS (Yale Brown Obsessive Compulsive Scale);
8. Desires for Drugs Questionnaire (DDQ);
9. Drug Use Self Report (DUSR);
10. Recent Drug Use Urinalysis (RDUU).
- Secondary outcome1. 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).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. Lonneke Nimwegen, van
- CONTACT for SCIENTIFIC QUERIESDrs. Lonneke Nimwegen, van
- Sponsor/Initiator Academic Medical Center (AMC), Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
Eli Lilly Nederland B.V.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-jul-2005 - 2-dec-2009


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