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

Schizophrenia Clinical Trial

Official title:

Observational, Non-interventional Registry to Assess Medication Usage Patterns in Clinical Routine Practice, in Subjects Receiving Antipsychotic Treatment With Risperidone Long Acting Injectable (Gluteal or Deltoid) or Oral Antipsychotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026285
• Other study ID #: CR016630
• Secondary ID: RISSCH4230
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2009
• Last updated: June 21, 2013
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2013
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the EnvironmentGermany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

International Observational Registry on Schizophrenia

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1085
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone Long-Acting injectable or oral antipsychotics
According to label

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Greece,  Russian Federation,  South Africa,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment		1, 3, 6, 9, 12 month	No
Secondary	To explore relevant factors for patient adherence to treatment		1, 3, 6, 9, 12 month	No
Secondary	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	No
Secondary	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	No

External Links

•   InORS - International Observational Registry on Schizophrenia