Subjective well-being, craving for Cannabis and compliance or medication switch in a randomised double blind study with Olanzapine and Risperidone

Completed

Conditions: Schizophrenia, schizo-affective disorder, schizofreniform disorder
Mental and Behavioural Disorders
Schizophrenia

Registration Number: ISRCTN46365995

Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Subjective Well-Being Under Neuroleptics Scale (SWN)<br>2. Obsessive Compulsive Drug Use Scale (OCDUS)<br>3. Positive And Negative Symptoms Scale (PANSS) based on information from the semi-structured interview (SCI-PANSS)<br>4. Calgary Depression Rating Scale (CDRS)<br>5. Extra-Pyramidal Symptom Rating Scale (ESRS)<br>6. Clinical Global Impression (CGI)<br>7. Yale Brown Obsessive Compulsive Scale (Y-BOCS)<br>8. Desires for Drugs Questionnaire (DDQ)<br>9. Drug Use Self Report (DUSR)<br>10. Recent Drug Use Urinalysis (RDUU)

Secondary Outcome Measures

Name	Time	Method
1. Drop out from the study<br>2. Medication compliance and medication switch, symptoms and rehospitalisations during one year follow up, measured with the Life Chart Schedule (LCS)