SchizophreniaNCT01026285
InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics
An observational study of Schizophrenia, run by Janssen-Cilag International NV at 98 sites in 8 countries.
Trial summary
International Observational Registry on Schizophrenia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone Long-Acting injectable or oral antipsychotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,085 participants
- Where
- 98 sitesin 8 countries
- Study dates
- Jun 2009to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with schizophrenia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
98 sites in 8 countries.
98 sites in 8 countries
Germany40 sites
Study site
Augsburg
Study site
Bad Honnef
Study site
Berlin
Study site
Bochum
Study site
Butzbach
Study site
Chemnitz
Study site
Coesfeld
Study site
Cologne
Study site
Dortmund
Study site
Dresden
Study site
Düsseldorf
Study site
Ebensfeld
Study site
Frankfurt
Study site
Fürth
Study site
Geithain
Study site
Greifswald
Study site
Grevenbroich
Study site
Hamburg
Study site
Ilmenau
Study site
Köthen
Study site
Krefeld
Study site
Leipzig
Study site
Limburg
Study site
Löhne
Study site
Magdeburg
Study site
Mannheim
Study site
München
Study site
Neuss
Study site
Oranienburg
Study site
Plauen
Study site
Potsdam
Study site
Riesa
Study site
Schleswig
Study site
Stolberg
Study site
Stralsund
Study site
Ulm
Study site
Velbert
Study site
Wetzlar
Study site
Wismar
Study site
Wuppertal
France20 sites
Study site
Bar-le-Duc
Study site
Boulogne-Billancourt
Study site
Bourg-en-Bresse
Study site
Challans
Study site
Créteil
Study site
Dax
Study site
La Roche-sur-Yon
Study site
La Seyne-sur-Mer
Study site
Laxou
Study site
Marseille
Study site
Mont-Saint-Martin
Study site
Montpellier
Study site
Morlaix
Study site
Plouguernével
Study site
Rennes
Study site
Saint-Avé
Study site
Saint-Égrève
Study site
Sarreguemines
Study site
Verdun
Study site
Villejuif
Turkey (Türkiye)10 sites
Study site
Adana
Study site
Ankara
Study site
Erzurum
Study site
Eskişehir
Study site
Istanbul
Study site
Izmir
Study site
Kocaeli
Study site
Manisa
Study site
Mersin
Study site
Trabzon
Greece8 sites
Study site
Arta
Study site
Athens
Study site
Chania
Study site
Crete
Study site
Ioannina
Study site
Larissa
Study site
Thessalonikis
Study site
Véroia
Spain8 sites
Study site
A Coruña
Study site
Burgos
Study site
Getafe
Study site
Madrid
Study site
Monforte de Lemos
Study site
Salamanca
Study site
Valladolid
Study site
Vigo
Czechia6 sites
Study site
Brno
Study site
České Budějovice
Study site
Most
Study site
Olomouc
Study site
Prague
Study site
Přerov
Russia4 sites
Study site
Kronshtadt
Study site
Nizhny Novgorod
Study site
Saint Petersburg
Study site
Yekaterinburg
About this study
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
Read the 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
- Conditions
- Schizophrenia
- Being tested
- Risperidone Long-Acting injectable or oral antipsychotics
- Keywords
- Risperdal Consta
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone Long-Acting injectable or oral antipsychoticsDrug
According to label
| Study group | Role | What they receive |
|---|---|---|
| antipsychotic treatment | Risperidone Long-Acting injectable or oral antipsychotics According to label Receives: Drug: Risperidone Long-Acting injectable or oral antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments
Measured: baseline, month 1, 3, 6, 9 & 12
Secondary outcomes (5)
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
Measured: 1, 3, 6, 9, 12 month
To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment
Measured: 1, 3, 6, 9, 12 month
To explore relevant factors for patient adherence to treatment
Measured: 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
Measured: 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
Measured: 1, 3, 6, 9, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026285
- Sponsor's protocol ID
- CR016630
- Other IDs
- RISSCH4230
- Status last verified
- Jun 2013
- First submitted
- 3 Dec 2009
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01026285
- Acronym / sponsor ID
- CR016630
- Conditions
- Schizophrenia
- Keywords
- Risperdal Consta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
International Observational Registry on Schizophrenia
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antipsychotic treatment | – | Drug: Risperidone Long-Acting injectable or oral antipsychoticsRisperidone Long-Acting injectable or oral antipsychotics According to label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with schizophrenia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone Long-Acting injectable or oral antipsychoticsAccording to label | Drug | antipsychotic treatment |
Primary outcome
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
5 secondary outcomes
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
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
To explore relevant factors for patient adherence to treatment
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- InORS - International Observational Registry on SchizophreniaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
98 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag International NV at 98 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in Germany, France, Turkey (Türkiye), Greece, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.