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

Phase 3

Conditions: verslaving
addiction
psychosis
schizophrenia
substance abuse
10039628
10024450

Registration Number: NL-OMON32733

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 140

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 very large percentage of the targetgroup.
Patients should be able to understand the study information and procedures and give informed consent.

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 excepted)
- 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 10 9/l
- Current neutrophilic granulocyte level lower than 2.0x 10 9/l

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. At baseline, week 4, week 8, month 6 or at moment of withdrawal from the<br /><br>study: Self reported substance use - CIDI section B,J,L and Recent Drug Use<br /><br>Urinalysis<br /><br>2. Cost-effectiveness - lncremental cost-effectiveness ratio (ICER): difference<br /><br>in costs/the difference in effectiveness (clozapine-olanzapine). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Direct and indirect medical costs, and non-medical costs<br /><br>2. Other clinical outcome: - Psychopathology: PANSS, YBOCS, OCDUS, QoL, SWN,<br /><br>CGI, GAF, LCS,<br /><br>- Adverse effects: - leucopoenia, agranulocytosis, - Time to non- compliance, -<br /><br>Time to withdrawal from study, - Quality of life, Quality adjusted life years<br /><br>(QALYs)</p><br>