E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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?
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E.2.2 | Secondary objectives of the trial |
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? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |