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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22184

Enrollment

120

Registered

2004-11-22

Start date

2003-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 disclos

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Contacts

Public ContactLonneke Nimwegen, van

Erasmus MC 's Gravendijkwal 230

+31 (0)10 4635871

Outcome results