Schizophrenia Clinical Trial
Official title:
Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia
This study is designed to compare the efficacy and drug tolerability of two strategies for the treatment of schizophrenia. The two strategies consist of utilizing, on the one hand, a conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with schizophrenia.
There is agreement in the psychiatry community that the so-called atypical antipsychotics
should be considered first choice in the treatment of schizophrenic disorders. However, the
general superiority of these newer antipsychotic drugs over the older conventional drugs
could not be clearly demonstrated in recent controlled clinical trials. The discrepancy
between every day's clinical perception and the results of clinical trials raises the
question whether the studies performed so far employed the adequate methodological approach
to represent the daily practice situation which is characterized by a wide variety of
duration and type of the schizophrenic disorder, concomitant diseases, and medications.
Moreover, some studies might not have been focused adequately on patient-relevant outcome
variables.
The present study project is designed to answer these open questions. The innovative
character of the study design is
1. that different neuroleptic strategies will be compared rather than single antipsychotic
drugs, using
2. an enhanced biometric design, that provides a choice of treatment with respect to the
individual patient though the trial as such is randomised controlled and double blind;
3. that clinically relevant endpoints such as quality of life will be the primary
variables, and
4. inclusion and exclusion criteria lead to a study population representing clinical every
day practice as near as possible.
Another innovatory procedure is that serum levels of the study drugs will be recorded twice
during the study. The authors hope that their design might yield transfer effects for other
clinical trials facing similar problems.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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