NCT01248195

Optimization of Treatment and Management of Schizophrenia in Europe

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Rene Kahn · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizophreniform Disorder
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Amisulpride open label	4-week open label amisulpride treatment
DRUG	6-week amisulpride double blind treatment	6-week amisulpride double blind treatment
DRUG	6-week olanzapine double blind treatment	6-week olanzapine double blind treatment
DRUG	12-week clozapine open-label treatment	12-week clozapine open-label treatment
BEHAVIORAL	Psychosocial intervention	Psychosocial intervention

Timeline

• Start date: 2011-05-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2010-11-25
• Last updated: 2018-05-15

Locations

26 sites across 16 countries: Australia, Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, Switzerland, United Kingdom