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

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ClinicalTrials.gov Identifier: NCT01026285
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
International Observational Registry on Schizophrenia

Condition or disease Intervention/treatment
Schizophrenia Drug: Risperidone Long-Acting injectable or oral antipsychotics

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 Type : Observational
Actual Enrollment : 1085 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Group/Cohort Intervention/treatment
antipsychotic treatment
Risperidone Long-Acting injectable or oral antipsychotics According to label
Drug: Risperidone Long-Acting injectable or oral antipsychotics
According to label




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To explore relevant factors for patient adherence to treatment [ Time Frame: 1, 3, 6, 9, 12 month ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01026285     History of Changes
Other Study ID Numbers: CR016630
RISSCH4230 ( Other Identifier: Janssen-Cilag International NV, Belgium )
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Janssen-Cilag International NV:
Risperdal Consta

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents