InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Risperidone Long-Acting injectable or oral antipsychotics

Study type: Observational

Funder types: Industry

Identifiers

NCT01026285

CR016630

RISSCH4230 (Other Identifier)

Details and patient eligibility

About

International Observational Registry on Schizophrenia

Full 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

Enrollment: 1,085 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,085 participants in 1 patient group

antipsychotic treatment

Description:

Risperidone Long-Acting injectable or oral antipsychotics According to label

Treatment:

Drug: Risperidone Long-Acting injectable or oral antipsychotics