Schizophrenia
Conditions
Keywords
Risperdal Consta
Brief summary
International Observational Registry on Schizophrenia
Detailed description
This is an observational, non-interventional registry designed to assess medication usage patterns and to explore, in clinical routine practice, long-term outcomes and relevant factors for patient adherence to treatment, in patients receiving antipsychotic treatment with risperidone long-acting injectable (RLAI) or oral antipsychotics. Six month retrospective data and 1 year prospective data will be collected. According to label
Interventions
DRUGRisperidone Long-Acting injectable or oral antipsychotics
According to label
Sponsors
Janssen-Cilag International NV
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must satisfy the following criteria to be eligible for documentation in this non-interventional study: Diagnosis of schizophrenia as well as 6 months of retrospective clinical records * Newly initiated on or switched to RLAI or an oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago * Signed informed consent (either signed by the patient or his/her legal representative) is available at the beginning of documentation * any schizophrenic patient (including those for whom a legal representative must sign consent) can be involved in the study
Exclusion criteria
* Established treatment refractory schizophrenia, defined as treatment failures with adequate trials (adequate as judged by the treating physician) of more than 2 second generation (atypical) antipsychotics and/or clozapine * History of neuroleptic malignant syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments | baseline, month 1, 3, 6, 9 & 12 |
Secondary
| Measure | Time frame |
|---|---|
| To collect 6-month retrospective and 1-year prospective data to allow the exploration of treatment outcomes including hospitalizations and rehospitalizations, with RLAI and oral antipsychotics, in relation to previous treatments | 1, 3, 6, 9, 12 month |
| To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment | 1, 3, 6, 9, 12 month |
| To explore relevant factors for patient adherence to treatment | 1, 3, 6, 9, 12 month |
| To document clinical effectiveness and functionality of patients on RLAI and oral antipsychotics in daily clinical practice (as measured by the Global Assessment of Functioning [GAF] scale | 1, 3, 6, 9, 12 month |
| Long-term safety data of RLAI (25, 37.5 or 50 mg every 2 weeks) and oral antipsychotics will be collected | 1, 3, 6, 9, 12 month |
Countries
Czechia, France, Germany, Greece, Russia, South Africa, Spain, Turkey (Türkiye)
Outcome results
None listed