schizophrenia substance abuse or dependence clozapine olanzapine double blind randomized
Conditions
Interventions
RCT: olanzapine or clozapine. In the first period the study
drug dose is titrated over 4 weeks according to a fixed dose schedule (see attached scheme).
All patients in both treatment arms will recei
Sponsors
ZonMW
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia or schizoaffective disorder or schizophreniform disorder according to DSM-IV with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID-P) 2. Diagnosis of Substance Use Disorder according to DSM IV 3. Age between 18-50 years (extremes included) 4. Patients should be able to understand the study description and give informed consent after detailed information
Exclusion criteria
Exclusion criteria: Detailed exclusion criteria 1. Pregnancy 2. Lactating women 3. Female subject without adequate contraception 4. Known hypersensitivity to any ingredient of clozapine or olanzapine 5. Concomitant use of any other antipsychotic drug than clozapine or olanzapine 6. Preferred use of other psychotropic medication other than oxazepam or biperideen 7. Narrow-angle glaucoma 8. Known neurological or endocrine disease 9. Myeloproliferative disorder 10. Uncontrolled epilepsy 11. History of clozapine-induced severe granulocytopenia 12. Paralytic ileus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy measures: at baseline, week 4, week 8, month 6 and at moment of unblinding: Self reported drug use - CIDI SAM: self-report substance use - Recent Drug Use Urinalysis (RDUU): a laboratory semiquantitative test on the presence of cannabis, heroin,cocaine and amphetamines (including XTC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychopathology: - Positive and negative symptoms: Positive And Negative Syndrome Scale (PANSS) (Kay et al., 1989) based on Information collected in a semi-structured interview (SCI-PANSS) - (Re) admission in psychiatric and course of symptoms in psychiatric hospital during 6 months as measured with the LCS (Susser et al, 2000) at baseline and at month 6 - Y-BOCS at baseline and at month 6 Adverse effects:- leukopenia, agranulocytosis (clozapine), weekly blood count during 16 week than monthly - weight gain - ESRS: Extra pyramidal Symptom Rating Scale (Chouinard) - Time to non- compliance as assessed by the central as assessed with the Treatment Compliance Interview, Patient and Clinicians Version (Weiden et al.) - Drop-out Quality of life/utility: - EuroQol 5-D questionnaire: In the EQ-5D approach,health related quality of life is conceptualized as having physical, mental, and social domains. The patients will be asked to classify themselves on five dimensions of health, each with three levels of dysfunction: mobility, self-care, usual activities, discomfort, and anxiety/depression. - Global Assessment of functioning (GAF) scale - Quality adjusted life years (QALYs). To this end, data on survival and quality of life (utility scores at baseline and 6 months weeks), measured by the the EQ-5D will be collected Costs - Costs associated with schizophrenia and SUD’s (S+SUD) from a societal perspective, this includes direct and indirect medical costs, and non-medical costs: 1. Direct S+SUD related health care costs: will be collected from a treatment inventory, pharmacy records (will be collected retrospectively) and information from the specialist. 2. Direct non-medical costs: cost for travelling. 3. lndirect non-medical costs (costs due to productivity losses) Health and Labor Questionnaire: self-administered instrument with proven ability to measure absence from work, reduced productivity at paid work, unpaid labour production and impediments t | — |
Contacts
Public ContactL. Haan, de
AMC-Academisch Psychiatrisch Centrum Meibergdreef 5 Adolescentenkliniek PA0-158
Outcome results
None listed