Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Olanzapine; Flupentixol; Quetiapine; Aripiprazole; Haloperidol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Olanzapine 10, 15, or 20 mg / day; Flupentixol 6, 9, or 12 mg / day; Quetiapine 400, 600, or 800 mg / day; Aripiprazole 10, 15, or 20 mg / day; Haloperidol 3, 4.5, or 6 mg / day
Intervention MeSH terms: Haloperidol; Olanzapine; Aripiprazole; Quetiapine Fumarate; Haloperidol decanoate; Flupenthixol; Flupenthixol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; atypical antipsychotic drugs; conventional antipsychotic drugs; olanzapine; quetiapine; aripiprazole; haloperidol; flupentixol