Schizophrenia Clinical Trial
Official title:
Olanzapine Augmentation in Clozapine-resistant Schizophrenia: a Randomized Double-blind Study
The aim of this randomized, double-blind study is to verify the hypothesis that clozapine
monotherapy is as efficient as a combination of clozapine and olanzapine therapy in
treatment-resistant schizophrenia.
A third of schizophrenia patients are non -responders to medications used nowadays. These
patients are usually treated with clozapine, but a large proportion of patients don't
recover sufficiently. Therefore, these patients are treated with combination of two or more
drugs to achieve better treatment results. Until now the scientific evidence has been
insufficient to assess the utility of polypharmacy.
The aim is to study during 2009 with voluntary patients, if there is any benefit of
olanzapine augmentation compared with pure clozapine monotherapy. During the study the
patients are not exposed to any additional intervention. The intervention in this study is
just to reduce the previously used polypharmacy.
Methods: This study lasts for 24 weeks. Participants (30) are randomized in one of two
alternative interventions (A or B) before the study. After 12 weeks the intervention arms
cross over (from A to B and from B to A).
Group B: In addition to clozapine, the participants receive their normal dosage of
olanzapine (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of
olanzapine for four weeks and subsequently placebo for 8 weeks
Group A: : In addition to clozapine the participants receive the decreasing dosage of
olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of
olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks
The response for the medical treatment is assessed by Clinical Global Improvement Scale
(CGIS) and Global Assessment of Functioning (GAF) -scale.
The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the
first 12 weeks). The second phase (the last 12 weeks) of the cross-over study is used in the
secondary analysis. The use of additional medication (such as benzodiazepines) is used as a
secondary outcome measure.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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