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.
Conditions
Interventions
Product Name: Olanzapine
Pharmaceutical Form: Coated tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539061
Product Name: clozapine
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOZAPINE
CA
Sponsors
AMC- academisch psychiatrisch centrum
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary research questions: 1. Is there a difference in effectiveness of clozapine treatment compared to olanzapine treatment in the reduction of substance use disorders of patients with schizophrenia and related psychotic disorders? 2. What is the Incremental cost-effectiveness ratio (ICER): the difference in costs / difference in effectiveness of clozapine treatment compared to olanzapine treatment? ;Secondary Objective: Secondary research questions: 1. Are there differences in direct medical costs, and direct indirect and non-medical costs between clozapine treatment and olanzapine treatment? 2. Are there differences in effectiveness of clozapine treatment compared to olanzapine treatment in: psychopathology, adverse effects, compliance, drop out rate, psychosocial functioning and quality of life?;Primary end point(s): 1. Self-reported drug use-CIDI BJL: self-report substance use at baseline, week 4, week 8 and month 6. Recent Drug Use Urine analysis (RDUU): a laboratory semiquantitative test on the presence of cannabis, heroin, cocaine and amphetamines (including XTC) at baseline, week 4, week 8 and month 6. Urine analysis will be performed in central laboratory facility (Lab of JellinekMentrum). 2. Cost-effectiveness: - lncremental cost-effectiveness ratio (ICER): difference in effectiveness (clozapine-olanzapine)/ the difference in costs | — |
Countries
Netherlands
Outcome results
None listed