SchizophreniaRESHAPENCT05480046
Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse
An observational study of Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 77 sites in 5 countries.
Trial summary
This is a prospective, non-interventional, multicentre study designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia who are suffering an acute exacerbation, according to routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone ISM
- How many people
- 275 participants
- Where
- 77 sitesin 5 countries
- Study dates
- 18 Oct 2022to 13 Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 diagnosed with schizophrenia who are admitted to a psychiatric unit due to a relapse and initiate treatment with Risperidone ISM (OKEDI®), according to the therapeutic indication of the marketing authorization ("Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone") under routine clinical practice.
Who may be able to join
- Patient aged 18 years or older at the time of hospitalisation.
- Patient with diagnosis of schizophrenia, as per clinical judgment.
- Patient admitted to a psychiatric inpatient unit due to an acute exacerbation.
- Patient has started treatment with Risperidone ISM within the previous 48 hours, according to the current Summary of Product Characteristics (SmPC).
- Patient or their legal representative provides written informed consent to participate in the study.
Who cannot join
- Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders.
- Patient with substance-induced psychosis or psychosis during intoxication (patients with comorbid substance abuse/dependence are allowed).
- Patient unable to answer the study questionnaires.
- Patient who is currently participating in another clinical study.
- Patient pregnant or breast-feeding.
- Patient with a serious and unstable medical condition, forensic patients, or patients with any contraindication mentioned in the SmPC of Risperidone ISM.
- Patients currently on antipsychotic treatment with clozapine or any long-acting injectable antipsychotic.
Trial locations and contacts
77 sites in 5 countries.
77 sites in 5 countries
Spain30 sites
Investigational site number ES-03
Barcelona
Investigational site number ES-45
Barcelona
Investigational site number ES-81
Barcelona
Investigational site number ES-16
Burgos
Investigational site number ES-23
Córdoba
Investigational site number ES-11
Granada
Investigational site number ES-59
Huesca
Investigational site number ES-21
Jaén
Investigational site number ES-70
Jerez de la Frontera
Investigational site number ES-72
L'Hospitalet de Llobregat
Investigational site number ES-60
Las Palmas de Gran Canaria
Investigational site number ES-49
Lleida
Investigational site number ES-51
Lugo
Investigational site number ES-19
Madrid
Investigational site number ES-24
Madrid
Investigational site number ES-66
Madrid
Investigational site number ES-63
Majadahonda
Investigational site number ES-04
Manacor
Investigational site number ES-73
Manresa
Investigational site number ES-65
Mataró
Investigational site number ES-14
Móstoles
Investigational site number ES-18
Murcia
Investigational site number ES-52
Ourense
Investigational site number ES-62
Ponferrada
Investigational site number ES-69
Santander
Investigational site number ES-02
Talavera de la Reina
Investigational site number ES-42
Torrejón
Investigational site number ES-76
Úbeda
Investigational site number ES-31
Vigo
Investigational site number ES-40
Vitoria-Gasteiz
Germany21 sites
Investigational site number DE-06
Aachen
Investigational site number DE-14
Ansbach
Investigational site number DE-23
Bayreuth
Investigational site number DE-10
Berlin
Investigational site number DE-12
Berlin
Investigational site number DE-15
Berlin
Investigational site number DE-07
Bonn
Investigational site number DE-16
Bonn
Investigational site number DE-02
Chemnitz
Investigational site number DE-03
Dortmund
Investigational site number DE-25
Eberswalde
Investigational Site number DE-01
Essen
Investigational site number DE-08
Greifswald
Investigational site number DE-22
Hamburg
Investigational site number DE-20
Hemer
Investigational site number DE-19
Leipzig
Investigational site number DE-05
Mannheim
Investigational site number DE-09
München
Investigational site number DE-04
Munich
Investigational site number DE-24
Neustadt
Investigational site number DE-13
Werneck
Italy15 sites
Investigational site number IT-32
Ancona
Investigational site number IT-19
Bolzano
Investigational site number IT-24
Brescia
Investigational site number IT-65
Brindisi
Investigational site number IT-20
Crema
Investigational site number IT-41
Foggia
Investigational site number IT-03
Legnano
Investigational site number IT-47
Manfredonia
Investigational site number IT-06
Milan
Investigational site number IT-42
Milan
Investigational site number IT-18
Montichiari
Investigational site number IT-113
Palermo
Investigational site number IT-44
Putignano
Investigational site number IT-97
Sant'Agata di Militello
Investigational site number IT-90
Vimercate
Portugal10 sites
Investigational site number PT-25
Beja
Investigational site number PT-24
Braga
Investigational site number PT-01
Coimbra
Investigational site number PT-33
Funchal
Investigational site number PT-36
Funchal
Investigational site number PT-20
Guarda
Investigational site number PT-32
Portimão
Investigational site number PT-13
Porto
Investigational site number PT-11
Santo Tirso
Investigational site number PT-27
Tomar
About this study
Official title: Risperidone ISM® Effectiveness in Schizophrenia Patients Hospitalised Due to A Relapse: a Prospective Non-interventional Evaluation (RESHAPE Study)
This is a prospective, non-interventional, multicentre study designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia who are suffering an acute exacerbation, according to routine clinical practice.
Read the detailed description
This is a non-interventional, multicentre, prospective study conducted in psychiatric inpatient units, and designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia and who are suffering an acute exacerbation, according to routine clinical practice.
The study comprises five visits in total:
Baseline Visit: This visit must be conducted within 48 hours after the first injection of Risperidone ISM. During this visit, the patient must meet all inclusion and exclusion criteria and sign the Informed Consent Form.
Follow-up Visit I: Scheduled approximately 8 ± 2 days after the first injection.
Follow-up Visit II: Scheduled approximately 28 ± 2 days after the first injection.
Discharge Visit: Conducted on the day of discharge, which may vary depending on the individual patient.
Final Visit: Occurs approximately 28 days after the second injection of Risperidone ISM and may be conducted in person or via telephone.
The study will be conducted in five visits: the Baseline Visit is the day on which the patient fulfils the inclusion and exclusion criteria, including signature of the Informed Consent; two follow-up visits will be scheduled after the first injection of Risperidone ISM; in addition, there will be another visit on the day of discharge; and the Final Visit will occur approximately 28 days after the 2nd injection of Risperidone ISM.
The primary objective of the study is to assess, under usual clinical practice, the effectiveness of Risperidone ISM in patients hospitalised due to a schizophrenia relapse.
The secondary objectives include:
Analysis of patterns of use of Risperidone ISM in hospital settings across several European countries.
Characterisation of patient profiles treated with Risperidone ISM in routine clinical practice.
Assessment of social functioning in schizophrenia patients treated with Risperidone ISM.
Evaluation of duration of hospitalisation across participating countries. Measurement of patient-reported treatment satisfaction. Evaluation of safety and tolerability of Risperidone ISM in routine clinical practice.
To assess these objectives, the following scales will be used:
PANSS-6: Baseline visit, Follow-up Visit I, Follow-up Visit II, and Final Visit.
CGI-S: Baseline visit, Follow-up Visit I, Follow-up Visit II, and Final Visit. PSP: Baseline visit, Follow-up Visit II, and Final Visit. MSQ: Baseline visit, Follow-up Visit II, and Final Visit.
Approximately 1,200 adults' patients were calculated to be enrolled in the sites from the participating countries.
The initial sample size estimation relied on an extremely small effect size that would be very unlikely given the results on a previous clinical trial with Risperidone ISM. After the examination of preliminary trial data and considering that the recruitment period was going to be longer than expected (mostly related to administrative issues for activating sites), the Sponsor has decided to re-evaluate the sample size required for the study. For this new estimation, the objective was to calculate the sample size that would allow to perform the analyses of the primary effectiveness variables not only in the total study population, but also in the subgroups who were pre-specified in the study protocol. Accordingly, the estimation was adjusted for each of the subgroups estimated share of the total study sample, and then accounted for the expected loss of patients, that was adjusted upwards to 35%. After that, the new sample size was set at approximately 272 patients.
- Conditions
- Schizophrenia
- Being tested
- Risperidone ISM
- Keywords
- Risperidone, Schizophrenia, Long-acting injectable
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone ISMDrug
Also called OKEDI®
Risperidone ISM is administered every 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Severity of Illness scale (CGI-S): change from baseline to Day 56.
The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome.
Measured: Baseline and Day 56 (or the last post-baseline assessment)
Positive and Negative Syndrome Scale (PANSS-6): change from baseline to Day 56.
The six-item version of the Positive and Negative Syndrome Scale (PANSS-6) is a 6-item scale derived from the full 30-item PANSS which evaluate: Delusions, Conceptual disorganization, Hallucinations, Blunted Affect, Social withdrawal and Lack of spontaneity and flow of conversation Safety and tolerability.
Measured: Baseline and Day 56 (or the last post-baseline assessment)
Secondary outcomes (4)
Personal and Social Performance (PSP) scale
The PSP is a 100-point single-item rating scale that is based on 4 areas: personal and social relationships; self-care; work and socially useful activities, and disturbing and aggressive behaviors. Each of the 4 domains is rated in 6 degrees of severity (absent, mild, manifest, marked, severe, very severe). Higher PSP scores indicate a better social functioning.
Measured: Baseline and Day 56 (or the last post-baseline assessment)
Medication Satisfaction Questionnaire (MSQ)
The Medication Satisfaction Questionnaire (MSQ) is a single-item, global, patient-completed instrument designed to assess treatment satisfaction among patients with schizophrenia. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied.
Measured: Day 56 (or the last post-baseline assessment)
Duration of hospitalisation
The duration of hospitalisation is the time from admission in the hospital to discharge.
Measured: Baseline and Day 56 (or the last post-baseline assessment)
Adverse drug reactions (ADR)
An adverse drug reaction (ADR), is a response to a study treatment that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the restoration, correction, or modification of physiological functions. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.
Measured: Up to Day 56 (or the last post-baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start18 Oct 2022
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph U Correll, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480046
- Sponsor's protocol ID
- ROV-RISP-2021-01
- Acronym
- RESHAPE
- Status last verified
- Nov 2025
- First submitted
- 20 Jul 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone ISM® Effectiveness in Schizophrenia Patients Hospitalised Due to A Relapse: a Prospective Non-interventional Evaluation (RESHAPE Study)
- ClinicalTrials.gov ID
- NCT05480046
- Acronym / sponsor ID
- RESHAPE / ROV-RISP-2021-01
- Conditions
- Schizophrenia
- Keywords
- Risperidone, Schizophrenia, Long-acting injectable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 29 Jul 2022 (actual)
- 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.
This is a prospective, non-interventional, multicentre study designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia who are suffering an acute exacerbation, according to routine clinical practice.
Detailed description
This is a non-interventional, multicentre, prospective study conducted in psychiatric inpatient units, and designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia and who are suffering an acute exacerbation, according to routine clinical practice.
The study comprises five visits in total:
Baseline Visit: This visit must be conducted within 48 hours after the first injection of Risperidone ISM. During this visit, the patient must meet all inclusion and exclusion criteria and sign the Informed Consent Form.
Follow-up Visit I: Scheduled approximately 8 ± 2 days after the first injection.
Follow-up Visit II: Scheduled approximately 28 ± 2 days after the first injection.
Discharge Visit: Conducted on the day of discharge, which may vary depending on the individual patient.
Final Visit: Occurs approximately 28 days after the second injection of Risperidone ISM and may be conducted in person or via telephone.
The study will be conducted in five visits: the Baseline Visit is the day on which the patient fulfils the inclusion and exclusion criteria, including signature of the Informed Consent; two follow-up visits will be scheduled after the first injection of Risperidone ISM; in addition, there will be another visit on the day of discharge; and the Final Visit will occur approximately 28 days after the 2nd injection of Risperidone ISM.
The primary objective of the study is to assess, under usual clinical practice, the effectiveness of Risperidone ISM in patients hospitalised due to a schizophrenia relapse.
The secondary objectives include:
Analysis of patterns of use of Risperidone ISM in hospital settings across several European countries.
Characterisation of patient profiles treated with Risperidone ISM in routine clinical practice.
Assessment of social functioning in schizophrenia patients treated with Risperidone ISM.
Evaluation of duration of hospitalisation across participating countries. Measurement of patient-reported treatment satisfaction. Evaluation of safety and tolerability of Risperidone ISM in routine clinical practice.
To assess these objectives, the following scales will be used:
PANSS-6: Baseline visit, Follow-up Visit I, Follow-up Visit II, and Final Visit.
CGI-S: Baseline visit, Follow-up Visit I, Follow-up Visit II, and Final Visit. PSP: Baseline visit, Follow-up Visit II, and Final Visit. MSQ: Baseline visit, Follow-up Visit II, and Final Visit.
Approximately 1,200 adults' patients were calculated to be enrolled in the sites from the participating countries.
The initial sample size estimation relied on an extremely small effect size that would be very unlikely given the results on a previous clinical trial with Risperidone ISM. After the examination of preliminary trial data and considering that the recruitment period was going to be longer than expected (mostly related to administrative issues for activating sites), the Sponsor has decided to re-evaluate the sample size required for the study. For this new estimation, the objective was to calculate the sample size that would allow to perform the analyses of the primary effectiveness variables not only in the total study population, but also in the subgroups who were pre-specified in the study protocol. Accordingly, the estimation was adjusted for each of the subgroups estimated share of the total study sample, and then accounted for the expected loss of patients, that was adjusted upwards to 35%. After that, the new sample size was set at approximately 272 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 diagnosed with schizophrenia who are admitted to a psychiatric unit due to a relapse and initiate treatment with Risperidone ISM (OKEDI®), according to the therapeutic indication of the marketing authorization ("Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone") under routine clinical practice.
Key inclusion criteria (5 listed)
- Patient aged 18 years or older at the time of hospitalisation.
- Patient with diagnosis of schizophrenia, as per clinical judgment.
- Patient admitted to a psychiatric inpatient unit due to an acute exacerbation.
- Patient has started treatment with Risperidone ISM within the previous 48 hours, according to the current Summary of Product Characteristics (SmPC).
- Patient or their legal representative provides written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders.
- Patient with substance-induced psychosis or psychosis during intoxication (patients with comorbid substance abuse/dependence are allowed).
- Patient unable to answer the study questionnaires.
- Patient who is currently participating in another clinical study.
- Patient pregnant or breast-feeding.
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 |
|---|---|---|
| Risperidone ISMAlso: OKEDI®Risperidone ISM is administered every 4 weeks | Drug | – |
Primary outcome
Clinical Global Impression-Severity of Illness scale (CGI-S): change from baseline to Day 56.
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome.
Positive and Negative Syndrome Scale (PANSS-6): change from baseline to Day 56.
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
The six-item version of the Positive and Negative Syndrome Scale (PANSS-6) is a 6-item scale derived from the full 30-item PANSS which evaluate: Delusions, Conceptual disorganization, Hallucinations, Blunted Affect, Social withdrawal and Lack of spontaneity and flow of conversation Safety and tolerability.
4 secondary outcomes
Personal and Social Performance (PSP) scale
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
Medication Satisfaction Questionnaire (MSQ)
Time frame: Day 56 (or the last post-baseline assessment)
Duration of hospitalisation
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
Adverse drug reactions (ADR)
Time frame: Up to Day 56 (or the last post-baseline assessment)
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 5 Dec 2025.
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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.
Christoph U Correll study chair
Charite University, Berlin, Germany
77 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 77 sites in 5 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 7 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in Spain, Germany, Italy, Portugal, United Kingdom. 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.
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?
Clinical Global Impression-Severity of Illness scale (CGI-S): change from baseline to Day 56. (time frame: Baseline and Day 56 (or the last post-baseline assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.