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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01026285
First received: December 3, 2009
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

International Observational Registry on Schizophrenia


Condition Intervention Phase
Schizophrenia
Drug: Risperidone Long-Acting injectable or oral antipsychotics
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments [ Time Frame: baseline, month 1, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ 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 ]

Enrollment: 1085
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
antipsychotic treatment
Risperidone Long-Acting injectable or oral antipsychotics According to label
Drug: Risperidone Long-Acting injectable or oral antipsychotics
According to label

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with schizophrenia

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026285

  Show 99 Study Locations
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01026285     History of Changes
Other Study ID Numbers: CR016630, RISSCH4230
Study First Received: December 3, 2009
Last Updated: June 21, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: Ethics Commission

Keywords provided by Janssen-Cilag International NV:
Risperdal Consta

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014