Status:
COMPLETED
Optimization of Treatment and Management of Schizophrenia in Europe
Lead Sponsor:
Rene Kahn
Collaborating Sponsors:
King's College London
Technical University of Munich
Conditions:
Schizophrenia
Schizophreniform Disorder
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief 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, ques...
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 gen...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia as defined by DSM-IV-R as determined by the M.I.N.I.plus
- Age 18 or older.
- The first psychosis occurred at least one year and no more than 7 years ago.\*
- If patients are using an antipsychotic drug, a medication switch is currently under consideration.
- Capable of providing written informed consent.
Exclusion
- Intolerance / hypersensitivity to one of the drugs (including active substances, metabolites and excipients) in this study including oral risperidone, paliperidone and aripiprazole and/or hypersensitivity to risperidone.
- Pregnancy or lactation.
- Patients who are currently using clozapine.
- Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
- Patients with a documented history of non-response and/or intolerance to any of the study medications and/or a documented history of non-response to a treatment with one of the study drugs of at least 6 weeks within the registered dose range.
- Forensic patients.
- Patients who have been treated with an investigational drug within 30 days prior to screening.
- Simultaneous participation in another intervention study (neither medication or psychosocial intervention).
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT01248195
Start Date
May 1 2011
End Date
April 1 2016
Last Update
May 15 2018
Active Locations (26)
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1
Melbourne Neuropsychiatry Centre
Melbourne, Australia, 3053
2
Department of Biological Psychiatry, Innsbruck University Clinics
Innsbruck, Austria, A-6020
3
Katholieke Universiteit Leuven (KU Leuven)
Leuven, Belgium, B - 3070
4
University Specialised Hospital for Active Treatment in Neurology and Psychiatry "St. Naum"
Sofia, Bulgaria, 1113