SchizophreniaPhase 4OPTIMISENCT01248195
Optimization of Treatment and Management of Schizophrenia in Europe
A Phase 4 study testing Amisulpride open label, 6-week amisulpride double blind treatment and 6-week olanzapine double blind treatment in people with Schizophrenia and Schizophreniform Disorder, run by Rene Kahn at 26 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Amisulpride open label, 6-week amisulpride double blind treatment and 6-week olanzapine double blind treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 26 sitesin 16 countries
- Study dates
- May 2011to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
26 sites in 16 countries.
26 sites in 16 countries
Spain5 sites
Hospital Clinic i Provincial
Barcelona, 08036 Barcelona
Servicio Madrileño de Salud (SERMAS)
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040 Madrid
Instituto de Investigación Hospital 12 de Octubre
Madrid, 28041 Madrid
Universidad de Oviedo
Oviedo, 33011 Oviedo
Germany4 sites
Martin-Luther-University (MLU) of Halle-Wittenberg
Halle, 06097
Deprtment of Psychiatry, University of Heidelberg
Mannheim, J 5, D-68159
Ludwig-Maximilians University München
München, 80336
Technische Universität München (TUM)
München, 81675
United Kingdom3 sites
King's College London, Departments of Psychological Medicine, Psychiatry & Cognitive Neuroscience
London, SE5 8AF
West London Mental Health Trust
London, W12 0NN
University of Manchester
Manchester, M13 9PL
Czechia2 sites
Psychiatrická klinika LF UK, Fakultní nemocnice
Hradec Králové, CZ - 500 05
Psychiatrické centrum Praha
Prague, Ustavni 91, 181 03 Praha 8-Bohnice
Austria1 site
Department of Biological Psychiatry, Innsbruck University Clinics
Innsbruck, A-6020
Bulgaria1 site
University Specialised Hospital for Active Treatment in Neurology and Psychiatry "St. Naum"
Sofia, 1113
Denmark1 site
Center for Neuropsychiatric Research
Glostrup Municipality, DK-2600
France1 site
Institut National de la Santé et de la Reserche Médicale (INSERM)
Créteil, 94010
Poland1 site
Department of Adult Psychiatry, University of Medical Sciences
Poznan, 60-572
Switzerland1 site
Clienia Schlössli AG, Privatklinik für Psychiatrie und Psychotherapie
Oetwil, CH-8618
About this study
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.
Read the 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.
- Being tested
- Amisulpride open label, 6-week amisulpride double blind treatment, 6-week olanzapine double blind treatment, 12-week clozapine open-label treatment, Psychosocial intervention
- Keywords
- Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Imaging, Prognosis, Treatment guidelines, Pharmacogenetics
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride open labelDrug
4-week open label amisulpride treatment
6-week amisulpride double blind treatmentDrug
6-week amisulpride double blind treatment
6-week olanzapine double blind treatmentDrug
6-week olanzapine double blind treatment
12-week clozapine open-label treatmentDrug
12-week clozapine open-label treatment
Psychosocial interventionBehavioural
Psychosocial intervention
| Study group | Role | What they receive |
|---|---|---|
| Phase I: 1 arm 'amisulpride open label' | Other | For 4 weeks, all patients will be treated with amisulpride open label. Receives: Drug: Amisulpride open label |
| Phase II: 'amisulpride double blind' | Active comparator | 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' Receives: Drug: 6-week amisulpride double blind treatment |
| Phase II 'olanzapine double blind' | Active comparator | 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' Receives: Drug: 6-week olanzapine double blind treatment |
| Phase III: 1 arm 'clozapine open label' | Other | 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' Receives: Drug: 12-week clozapine open-label treatment |
| Psychosocial intervention | Experimental | 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. Receives: Behavioral: Psychosocial intervention |
| Psychosocial Intervention phase: 'TAU' | No 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 'Treatment as usual' arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS
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.
Measured: Jan 2016
Sellwood rating scale
Psychosocial intervention component, objective A: drug adherence rates as a function of (standardized self report and) Sellwood rating scales after 12 and 52 weeks.
Measured: Jan 2016
Biological profile
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).
Measured: jan 2016
MRS measures
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.
Measured: jan 2016
SOFAS global functioning
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.
Measured: jan 2016
MRI assessments
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.
Measured: jan 2016
Secondary outcomes (4)
All cause treatment discontinuation
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).
Measured: jan 2016
All cause discontinuation
Psychosocial intervention component has multiple secondary objectives, most important one is all-cause treatment discontinuation between treatment groups after 12 and 52 weeks.
Measured: jan 2016
Biological markers
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.
Measured: jan 2016
MRI assessments
The ability of MRI to predict response to antipsychotic treatment in schizophrenia, after 4, 10 and 22 weeks.
Measured: jan 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rene Kahn
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Technical University of Munich, University of Manchester, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor-investigator, Rene Kahn, UMC Utrecht
- Investigators
- René Kahn, MD, PhD, Principal investigator, University Medical Center Utrecht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248195
- Sponsor's protocol ID
- KP7242114
- Other IDs
- 2010-020185-19
- Acronym
- OPTIMISE
- Status last verified
- May 2018
- First submitted
- 20 Oct 2010
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nasib LG, Winter-van Rossum I, Zuithoff NPA, Boudewijns ZSRM, Leucht S, Kahn RS. Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia: Comparing Outcome and Study Discontinuation of Groups of Participants in the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) Trial. J Clin Psychiatry. 2023 Mar 29;84(3):22m14531. doi: 10.4088/JCP.22m14531.
PubMed 36988483Fraguas D, Diaz-Caneja CM, Pina-Camacho L, Winter van Rossum I, Baandrup L, Sommer IE, Glenthoj B, Kahn RS, Leucht S, Arango C. The role of depression in the prediction of a "late" remission in first-episode psychosis: An analysis of the OPTiMiSE study. Schizophr Res. 2021 May;231:100-107. doi: 10.1016/j.schres.2021.03.010. Epub 2021 Apr 7.
PubMed 33838518Pollak TA, Vincent A, Iyegbe C, Coutinho E, Jacobson L, Rujescu D, Stone J, Jezequel J, Rogemond V, Jamain S, Groc L, David A, Egerton A, Kahn RS, Honnorat J, Dazzan P, Leboyer M, McGuire P. Relationship Between Serum NMDA Receptor Antibodies and Response to Antipsychotic Treatment in First-Episode Psychosis. Biol Psychiatry. 2021 Jul 1;90(1):9-15. doi: 10.1016/j.biopsych.2020.11.014. Epub 2020 Nov 24.
PubMed 33536130Kahn RS, Winter van Rossum I, Leucht S, McGuire P, Lewis SW, Leboyer M, Arango C, Dazzan P, Drake R, Heres S, Diaz-Caneja CM, Rujescu D, Weiser M, Galderisi S, Glenthoj B, Eijkemans MJC, Fleischhacker WW, Kapur S, Sommer IE; OPTiMiSE study group. Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study. Lancet Psychiatry. 2018 Oct;5(10):797-807. doi: 10.1016/S2215-0366(18)30252-9. Epub 2018 Aug 13.
PubMed 30115598
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Treatment and Management of Schizophrenia in Europe
- ClinicalTrials.gov ID
- NCT01248195
- Acronym / sponsor ID
- OPTIMISE / KP7242114
- Keywords
- Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Imaging, Prognosis, Treatment guidelines, Pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Rene KahnUniversity, hospital or other
- Collaborators
- King's College London, Technical University of Munich, University of Manchester, Ludwig-Maximilians - University of Munich
- Study start
- May 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase I: 1 arm 'amisulpride open label' | Other | Drug: Amisulpride open labelFor 4 weeks, all patients will be treated with amisulpride open label. |
| Phase II: 'amisulpride double blind' | Active comparator | Drug: 6-week amisulpride double blind treatmentPatients 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' |
| Phase II 'olanzapine double blind' | Active comparator | Drug: 6-week olanzapine double blind treatmentPatients 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' |
| Phase III: 1 arm 'clozapine open label' | Other | Drug: 12-week clozapine open-label treatmentPatients 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' |
| Psychosocial intervention | Experimental | Behavioral: Psychosocial interventionPatients 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. |
| Psychosocial Intervention phase: 'TAU' | No 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 'Treatment as usual' arm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amisulpride open label4-week open label amisulpride treatment | Drug | Phase I: 1 arm 'amisulpride open label' |
| 6-week amisulpride double blind treatment6-week amisulpride double blind treatment | Drug | Phase II: 'amisulpride double blind' |
| 6-week olanzapine double blind treatment6-week olanzapine double blind treatment | Drug | Phase II 'olanzapine double blind' |
| 12-week clozapine open-label treatment12-week clozapine open-label treatment | Drug | Phase III: 1 arm 'clozapine open label' |
| Psychosocial interventionPsychosocial intervention | Behavioural | Psychosocial intervention |
Primary outcome
PANSS
Time frame: Jan 2016
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.
Sellwood rating scale
Time frame: Jan 2016
Psychosocial intervention component, objective A: drug adherence rates as a function of (standardized self report and) Sellwood rating scales after 12 and 52 weeks.
Biological profile
Time frame: jan 2016
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).
MRS measures
Time frame: jan 2016
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.
SOFAS global functioning
Time frame: jan 2016
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.
MRI assessments
Time frame: jan 2016
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.
4 secondary outcomes
All cause treatment discontinuation
Time frame: jan 2016
All cause discontinuation
Time frame: jan 2016
Biological markers
Time frame: jan 2016
MRI assessments
Time frame: jan 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Derived from this study: PubMed 36988483Nasib LG, Winter-van Rossum I, Zuithoff NPA, Boudewijns ZSRM, Leucht S, Kahn RS. Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia: Comparing Outcome and Study Discontinuation of Groups of Participants in the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) Trial. J Clin Psychiatry. 2023 Mar 29;84(3):22m14531. doi: 10.4088/JCP.22m14531.
- Derived from this study: PubMed 33838518Fraguas D, Diaz-Caneja CM, Pina-Camacho L, Winter van Rossum I, Baandrup L, Sommer IE, Glenthoj B, Kahn RS, Leucht S, Arango C. The role of depression in the prediction of a "late" remission in first-episode psychosis: An analysis of the OPTiMiSE study. Schizophr Res. 2021 May;231:100-107. doi: 10.1016/j.schres.2021.03.010. Epub 2021 Apr 7.
- Derived from this study: PubMed 33536130Pollak TA, Vincent A, Iyegbe C, Coutinho E, Jacobson L, Rujescu D, Stone J, Jezequel J, Rogemond V, Jamain S, Groc L, David A, Egerton A, Kahn RS, Honnorat J, Dazzan P, Leboyer M, McGuire P. Relationship Between Serum NMDA Receptor Antibodies and Response to Antipsychotic Treatment in First-Episode Psychosis. Biol Psychiatry. 2021 Jul 1;90(1):9-15. doi: 10.1016/j.biopsych.2020.11.014. Epub 2020 Nov 24.
- Derived from this study: PubMed 30115598Kahn RS, Winter van Rossum I, Leucht S, McGuire P, Lewis SW, Leboyer M, Arango C, Dazzan P, Drake R, Heres S, Diaz-Caneja CM, Rujescu D, Weiser M, Galderisi S, Glenthoj B, Eijkemans MJC, Fleischhacker WW, Kapur S, Sommer IE; OPTiMiSE study group. Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study. Lancet Psychiatry. 2018 Oct;5(10):797-807. doi: 10.1016/S2215-0366(18)30252-9. Epub 2018 Aug 13.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Kahn, MD, PhD principal investigator
University Medical Center Utrecht, the Netherlands
26 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amisulpride open label, 6-week amisulpride double blind treatment and 6-week olanzapine double blind treatment in people with Schizophrenia and Schizophreniform Disorder, run by Rene Kahn at 26 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain, Germany, United Kingdom, Czechia, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS (time frame: Jan 2016). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.