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

June 21, 2013 updated by: Janssen-Cilag International NV

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1085

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
      • Ceske Budejovice, Czech Republic
      • Most, Czech Republic
      • Olomouc N/A, Czech Republic
      • Praha, Czech Republic
      • Prerov, Czech Republic
  • France
      • Bar Le Duc, France
      • Boulogne-Billancourt, France
      • Bourg En Bresse, France
      • Challans, France
      • Creteil, France
      • Dax, France
      • La Roche Sur Yon, France
      • La Seyne Sur Mer, France
      • Laxou Cedex, France
      • Marseille, France
      • Marseille Cedex 05, France
      • Mont St Martin, France
      • Montpellier, France
      • Morlaix Cedex, France
      • Plouguernevel, France
      • Rennes, France
      • Saint-Egreve, France
      • Sarreguemines, France
      • St Ave, France
      • Verdun, France
      • Villejuif, France
  • Germany
      • Augsburg, Germany
      • Bad Honnef, Germany
      • Berlin, Germany
      • Bochum, Germany
      • Butzbach, Germany
      • Chemnitz, Germany
      • Coesfeld, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Düsseldorf, Germany
      • Ebensfeld, Germany
      • Frankfurt, Germany
      • Fürth, Germany
      • Geithain, Germany
      • Greifswald, Germany
      • Grevenbroich, Germany
      • Hamburg, Germany
      • Ilmenau, Germany
      • Krefeld, Germany
      • Köln, Germany
      • Köthen, Germany
      • Leipzig, Germany
      • Limburg, Germany
      • Lohne, Germany
      • Magdeburg, Germany
      • Mannheim, Germany
      • München, Germany
      • Neuss, Germany
      • Oranienburg, Germany
      • Plauen, Germany
      • Potsdam, Germany
      • Riesa, Germany
      • Schleswig, Germany
      • Stolberg, Germany
      • Stralsund, Germany
      • Ulm, Germany
      • Velbert, Germany
      • Wetzlar, Germany
      • Wismar, Germany
      • Wuppertal, Germany
  • Greece
      • Arta, Greece
      • Athens, Greece
      • Chania, Greece
      • Crete, Greece
      • Ioannina, Greece
      • Larisa, Greece
      • Thessalonikis, Greece
      • Veroia, Greece
  • Russian Federation
      • Ekaterinburg, Russian Federation
      • Kronshtadt, Russian Federation
      • Nizhni Novgorod, Russian Federation
      • Saint-Petersburg, Russian Federation
  • South Africa
      • Pretoria, South Africa
    • AL
      • Birmingham, AL, South Africa
  • Spain
      • Burgos N/A, Spain
      • Coruña, Spain
      • Getafe, Spain
      • Madrid, Spain
      • Monforte De Lemos, Spain
      • Salamanca, Spain
      • Valladolid, Spain
      • Vigo, Spain
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Erzurum, Turkey
      • Eskisehir, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Kocaeli, Turkey
      • Manisa, Turkey
      • Mersin, Turkey
      • Trabzon, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with schizophrenia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
antipsychotic treatment
Risperidone Long-Acting injectable or oral antipsychotics According to label
Drug: Risperidone Long-Acting injectable or oral antipsychotics
According to label

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
baseline, month 1, 3, 6, 9 & 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
1, 3, 6, 9, 12 month
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
1, 3, 6, 9, 12 month
To explore relevant factors for patient adherence to treatment
Time Frame: 1, 3, 6, 9, 12 month
1, 3, 6, 9, 12 month
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
1, 3, 6, 9, 12 month
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
1, 3, 6, 9, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag International NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016630
  • RISSCH4230 (Other Identifier: Janssen-Cilag International NV, Belgium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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