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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN46365995 |
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Date of registration:
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16/05/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Subjective well-being, craving for Cannabis and compliance or medication switch in a randomised double blind study with Olanzapine and Risperidone
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Scientific title:
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Date of first enrolment:
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01/07/2003 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN46365995 |
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Study type:
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Interventional |
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Study design:
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Randomised, active controlled, parallel group, double-blinded trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Lonneke
van Nimwegen |
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Address:
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Academic Medical Centre
University of Amsterdam
Adolescent Clinic
Department of Psychiatry
Tafelbergweg 25
1105 BC
Amsterdam
Netherlands |
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Telephone:
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+31 (0)20 566 2142 |
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Email:
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L.J.vanNimwegen@amc.uva.nl |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia, schizo-affective disorder, schizofreniform disorder
Mental and Behavioural Disorders
Schizophrenia
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Intervention(s)
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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.
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Primary Outcome(s)
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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)
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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Eli Lilly (The Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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