Optimization of Treatment and Management of Schizophrenia in Europe
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is optimising current treatments in schizophrenia and explore novel
      therapeutic options for schizophrenia. The study intends to both address basic, but so far
      unanswered, questions in the treatment of schizophrenia and develop new interventions. It is
      expected that the project will lead to evidence that is directly applicable to treatment
      guidelines, and will identify potential mechanisms for new drug development.
    

Detailed description: 
      Despite nearly fifty years of pharmacological and psychosocial research, the overall
      prognosis of schizophrenia has improved only marginally. While the efficacy of most
      antipsychotic medication is generally uncontested, their overall functional impact has been
      modest. In order to improve this unsatisfactory result, this study aims to optimize current
      treatments in schizophrenia and explore novel therapeutic options for schizophrenia. The
      study comprises a medication intervention component, a psychosocial intervention component, a
      biological predictor component and an MRI component. MRI assessments are performed at
      baseline, and used to determine whether potential organic causes for psychotic symptoms are
      present, and to test prospective value of these assessments for subsequent treatment
      response. MRI assessments of healthy volunteers will be included to test for deviations in
      patients' assessments; these volunteers will not participate in any other protocol procedure.
      The medication intervention component comprises a first 4-week phase of amisulpride
      treatment. Non-responders will subsequently be randomised to a 6-week double blind phase on
      either amisulpride or olanzapine. Patients who classify as non-responders at the end of this
      phase, a 12-week open label treatment with clozapine is initiated. Patients who classify as a
      responder in phase I, II or III, are drop outs or who are non-responders at the end of phase
      III flow to the psychosocial intervention component of the study. During this part, several
      interventions are tested, aimed to increase treatment compliance and keep patients on the
      medication to which they've responded well. Through the biological predictor component, it is
      determined whether glutamatergic markers predict response to first and second line
      treatments, and if an empirical combination of pharmacogenetic, proteomics- and metabolomic
      markers can provide clinical valuable predictive value.
    

Intervention name(s): Amisulpride open label; 6-week amisulpride double blind treatment; 6-week olanzapine double blind treatment; 12-week clozapine open-label treatment; Psychosocial intervention
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral
Intervention description(s): 4-week open label amisulpride treatment; 6-week amisulpride double blind treatment; 6-week olanzapine double blind treatment; 12-week clozapine open-label treatment; Psychosocial intervention
Intervention MeSH terms: Olanzapine; Clozapine; Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophreniform disorder; Schizoaffective disorder; Imaging; Prognosis; Treatment guidelines; Pharmacogenetics