No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
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. 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 outcome
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).
Background summary
N/A
Study objective
N/A
Study design
N/A
Intervention
Patients 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.
's Gravendijkwal 230
Lonneke Nimwegen, van
Tafelbergweg 25
Rotterdam 3015 CE
The Netherlands
+31 (0)10 4635871
's Gravendijkwal 230
Lonneke Nimwegen, van
Tafelbergweg 25
Rotterdam 3015 CE
The Netherlands
+31 (0)10 4635871
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 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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4 |
| NTR-old | NTR28 |
| Other | : N/A |
| ISRCTN | ISRCTN46365995 |