Randomized Olanzapine Clozapine Key study on Schizophrenia and Addiction in the Netherlands (ROCKSAN) - ROCKSA

Conditions: A multi-centre prospective, randomized, double blind designed study examining the effectiveness and costs of clozapine compared to olanzapine in patients with schizophrenia or related psychotic disorders and co-morbid SUD. Study setting: in and out patients. Study duration: 6 months.

Registration Number: EUCTR2008-005019-16-NL

Lead Sponsor: AMC- academisch psychiatrisch centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Eligible for the study are in- and outpatients age 18 to 50, meeting DSM-IV criteria for schizophrenia, schizoaffective - or schizophreniform disorder and substance abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID-P).
Patients that are admitted under authority of the court should also be included, since this group embodies a large percentage of the targetgroup.
Patients should be able to understand the study information and procedures and give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy
- Lactating women
- Female subject without adequate contraception
- Known hypersensitivity to clozapine, olanzapine or ingredients used in these tablets
- Concomitant daily use of any antipsychotic other drug than clozapine or olanzapine (crisis intervention medication is permitted)
- Use of depot antipsychotics in the three months prior to inclusion
- Narrow-angle glaucoma
- Known neurological or endocrine disease interfering with clozapine or olanzapine treatment
- Myeloproliferative disorder
- Uncontrolled epilepsy
- History of treatment with clozapine in the past 12 months during at least 4 months at therapeutic serum levels
- Paralytic ileus
- Current leukocyte level lower than 3.5 x 109/l
- Current neutrophilic granulocyte level lower than 2.0x 109/l