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


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateNovember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2009)		prospectively assess medication usage patterns under routine clinical practice and collect prospective long-term treatment outcomes including hospitalization and rehospitalization, related to initiation of treatment with risperidone RLAI [ Time Frame: baseline, month 1, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01026285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 3, 2009)
  • 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 [ Time Frame: 1, 3, 6, 9, 12 month ] [ Designated as safety issue: No ]
  • To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment [ Time Frame: 1, 3, 6, 9, 12 month ] [ Designated as safety issue: No ]
  • To explore relevant factors for patient adherence to treatment [ Time Frame: 1, 3, 6, 9, 12 month ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1, 3, 6, 9, 12 month ] [ Designated as safety issue: No ]
  • Long-term safety data of RLAI (25, 37.5 or 50 mg every 2 weeks) and oral antipsychotics will be collected [ Time Frame: 1, 3, 6, 9, 12 month ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEInORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics
Official Title  ICMJEObservational, 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
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

Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJEOther, Prospective
Condition  ICMJESchizophrenia
Intervention  ICMJEDrug: Risperidone Long-Acting injectable or oral antipsychotics
According to label
Study Arms / Comparison Groups001
Risperidone Long-Acting injectable or oral antipsychotics According to label
Intervention: Drug: Risperidone Long-Acting injectable or oral antipsychotics

Recruitment Information

Estimated Enrollment  ICMJE1000
Estimated Completion DateNovember 2011
Estimated Primary Completion DateNovember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJEFrance,   Germany,   Greece,   Russian Federation,   Turkey

Administrative Information

NCT ID  ICMJENCT01026285
Responsible PartyEuropean Medical Affairs Director, Janssen-Cilag S.A., Spain
Study ID Numbers  ICMJECR016630, RISSCH4230
Study Sponsor  ICMJEJanssen-Cilag International NV
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Janssen-Cilag International NV Clinical TrialJanssen-Cilag International NV
Information Provided ByJanssen-Cilag International NV