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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01248195
Registration number
NCT01248195
Ethics application status
Date submitted
20/10/2010
Date registered
25/11/2010
Date last updated
15/05/2018
Titles & IDs
Public title
Optimization of Treatment and Management of Schizophrenia in Europe
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Scientific title
Optimization of Treatment and Management of Schizophrenia in Europe
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Secondary ID [1]
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2010-020185-19
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Secondary ID [2]
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KP7242114
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Universal Trial Number (UTN)
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Trial acronym
OPTIMISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Schizophreniform Disorder
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Schizoaffective Disorder
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Condition category
Condition code
Mental Health
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Schizophrenia
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Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amisulpride open label
Treatment: Drugs - 6-week amisulpride double blind treatment
Treatment: Drugs - 6-week olanzapine double blind treatment
Treatment: Drugs - 12-week clozapine open-label treatment
Behaviour - Psychosocial intervention
Other: Phase I: 1 arm 'amisulpride open label' - For 4 weeks, all patients will be treated with amisulpride open label.
Active Comparator: Phase II: 'amisulpride double blind' - Patients who do not meet remission criteria during phase I (4 weeks open label amisulpride), flow to phase II where they are randomised to 1 of 2 6-week double blind treatment arms, one of which is 'amisulpride double blind'
Active Comparator: Phase II 'olanzapine double blind' - Patients who do not meet remission criteria during phase I (4 weeks open label amisulpride), flow to phase II where they are randomised to 1 of 2 6-week double blind treatment arms, one of which is 'olanzapine double blind'
Other: Phase III: 1 arm 'clozapine open label' - Patients who do not meet remission criteria during phase II (6-week double blind amisulpride vs olanzapine), flow to phase III, where only 1 arm is available: 'clozapine open label'
Experimental: Psychosocial intervention - Patients who meet remission criteria during any of the phases of the medication component, patients who drop out of the medication component and patients who did not meet remission criteria at the end of the medication component, will flow to the psychosocial intervention component, where they are randomised to 1 of 2 arms, one of which is the 'Psychosocial Intervention' arm.
No Intervention: Psychosocial Intervention phase: 'TAU' - Patients who meet remission criteria during any of the phases of the medication component, patients who drop out of the medication component and patients who did not meet remission criteria at the end of the medication component, will flow to the psychosocial intervention component, where they are randomised to 1 of 2 arms, one of which is the 'Treatment as usual' arm.
Treatment: Drugs: Amisulpride open label
4-week open label amisulpride treatment
Treatment: Drugs: 6-week amisulpride double blind treatment
6-week amisulpride double blind treatment
Treatment: Drugs: 6-week olanzapine double blind treatment
6-week olanzapine double blind treatment
Treatment: Drugs: 12-week clozapine open-label treatment
12-week clozapine open-label treatment
Behaviour: Psychosocial intervention
Psychosocial intervention
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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PANSS
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Assessment method [1]
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Study consists of multiple components, each with their own objectives. For this (medication) component: number of patients in remission, based on PANSS scores (criteria of Andreasen et al.; 2005) after 4 weeks open label amisulpride, after 6 weeks double blind amisulpride or olanzapine and after 12 weeks of open label clozapine.
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Timepoint [1]
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Jan 2016
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Primary outcome [2]
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Sellwood rating scale
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Assessment method [2]
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Psychosocial intervention component, objective A: drug adherence rates as a function of (standardized self report and) Sellwood rating scales after 12 and 52 weeks.
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Timepoint [2]
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Jan 2016
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Primary outcome [3]
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Biological profile
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Assessment method [3]
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Biological predictors component, objective A: drug response (remission vs non-remission) as a function of biological profile, after 4 weeks, 10 weeks and 22 weeks (after each medication phase).
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Timepoint [3]
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jan 2016
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Primary outcome [4]
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MRS measures
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Assessment method [4]
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Biological predictors component, objective B: using MRS scans, differences between responders and non-responders in regional glutamate levels a) at baseline and b) between baseline and after one month of treatment with amisulpiride.
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Timepoint [4]
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jan 2016
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Primary outcome [5]
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SOFAS global functioning
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Assessment method [5]
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Psychosocial intervention component, objective B: drug adherence rates as a function of standardized global functioning (SOFAS score after 1 year) following psychosocial intervention vs treatment as usual.
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Timepoint [5]
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jan 2016
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Primary outcome [6]
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MRI assessments
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Assessment method [6]
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MRI component objective: the percentage of first episode patients that show radiological abnormalities suggestive of neurological disorders which may explain the occurrence of psychotic symptoms - measurement at baseline only.
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Timepoint [6]
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jan 2016
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Secondary outcome [1]
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All cause treatment discontinuation
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Assessment method [1]
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The different components of the study have their own secondary objectives:
Medication component has multiple secondary objectives, most important one is all-cause treatment discontinuation after 4 weeks, 10 weeks and 22 weeks. Number and reason for premature discontinuations (treatment discontinuation) of the amisulpride and the olanzapine group will be compared (after 10 weeks).
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Timepoint [1]
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jan 2016
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Secondary outcome [2]
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All cause discontinuation
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Assessment method [2]
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Psychosocial intervention component has multiple secondary objectives, most important one is all-cause treatment discontinuation between treatment groups after 12 and 52 weeks.
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Timepoint [2]
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jan 2016
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Secondary outcome [3]
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Biological markers
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Assessment method [3]
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Biological predictors component has multiple secondary objectives, most important one is the ability of biological markers to predict response to antipsychotic and treatment tolerability in schizophrenia, after 4, 10 and 22 weeks.
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Timepoint [3]
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jan 2016
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Secondary outcome [4]
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MRI assessments
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Assessment method [4]
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The ability of MRI to predict response to antipsychotic treatment in schizophrenia, after 4, 10 and 22 weeks.
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Timepoint [4]
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jan 2016
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Eligibility
Key inclusion criteria
1. Diagnosis of schizophrenia as defined by DSM-IV-R as determined by the M.I.N.I.plus
2. Age 18 or older.
3. The first psychosis occurred at least one year and no more than 7 years ago.*
4. If patients are using an antipsychotic drug, a medication switch is currently under
consideration.
5. Capable of providing written informed consent.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. 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.
2. Pregnancy or lactation.
3. Patients who are currently using clozapine.
4. Patients who do not fully comprehend the purpose or are not competent to make a
rational decision whether or not to participate.
5. 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.
6. Forensic patients.
7. Patients who have been treated with an investigational drug within 30 days prior to
screening.
8. Simultaneous participation in another intervention study (neither medication or
psychosocial intervention).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2016
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Sample size
Target
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Accrual to date
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Final
479
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Melbourne Neuropsychiatry Centre - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Innsbruck
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Country [2]
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Belgium
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State/province [2]
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Leuven
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Country [3]
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Bulgaria
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State/province [3]
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Sofia
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Country [4]
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Czechia
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State/province [4]
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Ustavni 91
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Country [5]
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Czechia
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State/province [5]
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Hradec Králové
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Country [6]
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Denmark
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State/province [6]
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Glostrup
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Country [7]
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France
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State/province [7]
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Créteil Cedex
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Country [8]
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Germany
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State/province [8]
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Halle
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Country [9]
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Germany
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State/province [9]
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Mannheim
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Country [10]
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Germany
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State/province [10]
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München
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Country [11]
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Israel
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State/province [11]
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Tel Hashomer
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Country [12]
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Italy
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State/province [12]
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Naples
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Country [13]
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Netherlands
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State/province [13]
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Utrecht
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Country [14]
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Poland
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State/province [14]
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Poznan
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Country [15]
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Romania
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State/province [15]
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Bucuresti
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Country [16]
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Spain
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State/province [16]
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Barcelona
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Country [17]
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Spain
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State/province [17]
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Madrid
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Country [18]
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Spain
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State/province [18]
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Oviedo
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Country [19]
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Switzerland
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State/province [19]
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Oetwil am See
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Country [20]
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United Kingdom
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State/province [20]
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London
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Country [21]
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United Kingdom
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State/province [21]
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Manchester
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rene Kahn
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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King's College London
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Technical University of Munich
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Manchester
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Ludwig-Maximilians - University of Munich
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
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, 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01248195
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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René Kahn, MD, PhD
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Address
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University Medical Center Utrecht, the Netherlands
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01248195
Download to PDF