Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse

Schizophrenia Clinical Trial

— RESHAPE  

Official title:

Risperidone ISM® Effectiveness in Schizophrenia Patients Hospitalised Due to A Relapse: a Prospective Non-interventional Evaluation (RESHAPE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480046
• Other study ID #: ROV-RISP-2021-01
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Rovi Pharmaceuticals Laboratories
• Contact: Javier Martínez
• Phone: 0034913756230
• Email: departamento.medico[@]rovi.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 will be enrolled in the sites from the participating countries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone ISM
Risperidone ISM is administered every 4 weeks

Locations

Country	Name	City	State
Germany	Klinik en Essen-Mitte - Klinik für Psychiatrie, Psychotherapie, Psychosomatik und Suchtmedizin	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Rovi Pharmaceuticals Laboratories

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Day 56 (or the last post-baseline assessment)
Primary	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.	Baseline and Day 56 (or the last post-baseline assessment)
Secondary	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.	Baseline and Day 56 (or the last post-baseline assessment)
Secondary	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.	Day 56 (or the last post-baseline assessment)
Secondary	Duration of hospitalisation	The duration of hospitalisation is the time from admission in the hospital to discharge.	Baseline and Day 56 (or the last post-baseline assessment)
Secondary	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.	Up to Day 56 (or the last post-baseline assessment)