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Completed

NCT Number: NCT01026285

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

International Observational Registry on Schizophrenia

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone Long-Acting injectable or oral antipsychotics

Drug

According to label

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Janssen-Cilag International NV

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2009
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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