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”

International Observational Registry on Schizophrenia

Study Type: Observational

Study Design: Time Perspective: Prospective

Study Primary Completion Date: November 2011

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• : 001
  • Risperidone Long-Acting injectable or oral antipsychotics According to label

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    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
    Safety Issue?: No
• To explore relevant factors for patient adherence to treatment
  • Time Frame: 1, 3, 6, 9, 12 month
    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
    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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen-Cilag International NV

Overall Clinical Trial Officials and Contacts

Janssen-Cilag International NV Clinical Trial Study Director Janssen-Cilag International NV  

Overall 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

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01026285

Study ID Number: CR016630

ClinicalTrials.gov Identifier: NCT01026285

Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

To learn how to participate in this trial please click here.