Clinical trial NCT05480046: Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse
Official title: Risperidone ISM® Effectiveness in Schizophrenia Patients Hospitalised Due to A Relapse: a Prospective Non-interventional Evaluation (RESHAPE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Risperidone
Schizophrenia
Long-acting injectable
Lead sponsor: Rovi Pharmaceuticals Laboratories
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient aged 18 years or older at the time of hospitalisation.
2. Patient with diagnosis of schizophrenia, as per clinical judgment.
3. Patient admitted to a psychiatric inpatient unit due to an acute exacerbation.
4. Patient has started treatment with Risperidone ISM within the previous 48 hours, according to the current Summary of Product Characteristics (SmPC).
5. Patient or their legal representative provides written informed consent to participate in the study.

Exclusion Criteria:

1. Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders.
2. Patient with substance-induced psychosis or psychosis during intoxication (patients with comorbid substance abuse/dependence are allowed).
3. Patient unable to answer the study questionnaires.
4. Patient who is currently participating in another clinical study.
5. Patient pregnant or breast-feeding.
6. Patient with a serious and unstable medical condition, forensic patients, or patients with any contraindication mentioned in the SmPC of Risperidone ISM.
7. Patients currently on antipsychotic treatment with clozapine or any long-acting injectable antipsychotic.

Primary outcomes:
measure: Clinical Global Impression-Severity of Illness scale (CGI-S): change from baseline to Day 56.
timeFrame: Baseline and Day 56 (or the last post-baseline assessment)
measure: Positive and Negative Syndrome Scale (PANSS-6): change from baseline to Day 56.
timeFrame: Baseline and Day 56 (or the last post-baseline assessment)
Secondary outcomes:
measure: Personal and Social Performance (PSP) scale
timeFrame: Baseline and Day 56 (or the last post-baseline assessment)
measure: Medication Satisfaction Questionnaire (MSQ)
timeFrame: Day 56 (or the last post-baseline assessment)
measure: Duration of hospitalisation
timeFrame: Baseline and Day 56 (or the last post-baseline assessment)
measure: Adverse drug reactions (ADR)
timeFrame: Up to Day 56 (or the last post-baseline assessment)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Investigational site number DE-06
city: Ansbach
country: Germany
facility: Investigational site number DE-14
city: Bayreuth
country: Germany
facility: Investigational site number DE-23
city: Berlin
country: Germany
facility: Investigational site number DE-10
city: Berlin
country: Germany
facility: Investigational site number DE-12
city: Berlin
country: Germany
facility: Investigational site number DE-15
city: Bonn
country: Germany
facility: Investigational site number DE-07
city: Bonn
country: Germany
facility: Investigational site number DE-16
city: Chemnitz
country: Germany
facility: Investigational site number DE-02
city: Dortmund
country: Germany
facility: Investigational site number DE-03
city: Eberswalde
country: Germany
facility: Investigational site number DE-25
city: Essen
country: Germany
facility: Investigational Site number DE-01
city: Greifswald
country: Germany
facility: Investigational site number DE-08
city: Hamburg
country: Germany
facility: Investigational site number DE-22
city: Hemer
country: Germany
facility: Investigational site number DE-20
city: Leipzig
country: Germany
facility: Investigational site number DE-19
city: Mannheim
country: Germany
facility: Investigational site number DE-05
city: Munich
country: Germany
facility: Investigational site number DE-04
city: München
country: Germany
facility: Investigational site number DE-09
city: Neustadt
country: Germany
facility: Investigational site number DE-24
city: Werneck
country: Germany
facility: Investigational site number DE-13
city: Ancona
country: Italy
facility: Investigational site number IT-32
city: Bolzano
country: Italy
facility: Investigational site number IT-19
city: Brescia
country: Italy
facility: Investigational site number IT-24
city: Brindisi
country: Italy
facility: Investigational site number IT-65
city: Crema
country: Italy
facility: Investigational site number IT-20
city: Foggia
country: Italy
facility: Investigational site number IT-41
city: Legnano
country: Italy
facility: Investigational site number IT-03
city: Manfredonia
country: Italy
facility: Investigational site number IT-47
city: Milano
country: Italy
facility: Investigational site number IT-06
city: Milano
country: Italy
facility: Investigational site number IT-42
city: Montichiari
country: Italy
facility: Investigational site number IT-18
city: Palermo
country: Italy
facility: Investigational site number IT-113
city: Putignano
country: Italy
facility: Investigational site number IT-44
city: Sant'Agata Di Militello
country: Italy
facility: Investigational site number IT-97
city: Vimercate
country: Italy
facility: Investigational site number IT-90
city: Beja
country: Portugal
facility: Investigational site number PT-25
city: Braga
country: Portugal
facility: Investigational site number PT-24
city: Coimbra
country: Portugal
facility: Investigational site number PT-01
city: Funchal
country: Portugal
facility: Investigational site number PT-33
city: Funchal
country: Portugal
facility: Investigational site number PT-36
city: Guarda
country: Portugal
facility: Investigational site number PT-20
city: Portimão
country: Portugal
facility: Investigational site number PT-32
city: Porto
country: Portugal
facility: Investigational site number PT-13
city: Santo Tirso
country: Portugal
facility: Investigational site number PT-11
city: Tomar
country: Portugal
facility: Investigational site number PT-27
city: Barcelona
country: Spain
facility: Investigational site number ES-03
city: Barcelona
country: Spain
facility: Investigational site number ES-45
city: Barcelona
country: Spain
facility: Investigational site number ES-81
city: Burgos
country: Spain
facility: Investigational site number ES-16
city: Córdoba
country: Spain
facility: Investigational site number ES-23
city: Granada
country: Spain
facility: Investigational site number ES-11
city: Huesca
country: Spain
facility: Investigational site number ES-59
city: Jaén
country: Spain
facility: Investigational site number ES-21
city: Jerez De La Frontera
country: Spain
facility: Investigational site number ES-70
city: L'Hospitalet De Llobregat
country: Spain
facility: Investigational site number ES-72
city: Las Palmas De Gran Canaria
country: Spain
facility: Investigational site number ES-60
city: Lleida
country: Spain
facility: Investigational site number ES-49
city: Lugo
country: Spain
facility: Investigational site number ES-51
city: Madrid
country: Spain
facility: Investigational site number ES-19
city: Madrid
country: Spain
facility: Investigational site number ES-24
city: Madrid
country: Spain
facility: Investigational site number ES-66
city: Majadahonda
country: Spain
facility: Investigational site number ES-63
city: Manacor
country: Spain
facility: Investigational site number ES-04
city: Manresa
country: Spain
facility: Investigational site number ES-73
city: Mataró
country: Spain
facility: Investigational site number ES-65
city: Murcia
country: Spain
facility: Investigational site number ES-18
city: Móstoles
country: Spain
facility: Investigational site number ES-14
city: Ourense
country: Spain
facility: Investigational site number ES-52
city: Ponferrada
country: Spain
facility: Investigational site number ES-62
city: Santander
country: Spain
facility: Investigational site number ES-69
city: Talavera De La Reina
country: Spain
facility: Investigational site number ES-02
city: Torrejón
country: Spain
facility: Investigational site number ES-42
city: Vigo
country: Spain
facility: Investigational site number ES-31
city: Vitoria-Gasteiz
country: Spain
facility: Investigational site number ES-40
city: Úbeda
country: Spain
facility: Investigational site number ES-76
city: London
country: United Kingdom
facility: Investigational site number GB-08
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christoph U Correll
role: STUDY_CHAIR
References: