Clinical trial NCT01026285: InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Risperdal Consta
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 1085
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with schizophrenia

Brief summary: 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

Eligibility 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

Primary outcomes:
measure: prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments
timeFrame: baseline, month 1, 3, 6, 9 & 12
Secondary outcomes:
measure: 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
timeFrame: 1, 3, 6, 9, 12 month
measure: To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment
timeFrame: 1, 3, 6, 9, 12 month
measure: To explore relevant factors for patient adherence to treatment
timeFrame: 1, 3, 6, 9, 12 month
measure: 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
timeFrame: 1, 3, 6, 9, 12 month
measure: Long-term safety data of RLAI (25, 37.5 or 50 mg every 2 weeks) and oral antipsychotics will be collected
timeFrame: 1, 3, 6, 9, 12 month
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Ceske Budejovice
country: Czech Republic
city: Most
country: Czech Republic
city: Olomouc N/A
country: Czech Republic
city: Praha
country: Czech Republic
city: Prerov
country: Czech Republic
city: Bar Le Duc
country: France
city: Boulogne-Billancourt
country: France
city: Bourg En Bresse
country: France
city: Challans
country: France
city: Creteil
country: France
city: Dax
country: France
city: La Roche Sur Yon
country: France
city: La Seyne Sur Mer
country: France
city: Laxou Cedex
country: France
city: Marseille Cedex 05
country: France
city: Marseille
country: France
city: Mont St Martin
country: France
city: Montpellier
country: France
city: Morlaix Cedex
country: France
city: Plouguernevel
country: France
city: Rennes
country: France
city: Saint-Egreve
country: France
city: Sarreguemines
country: France
city: St Ave
country: France
city: Verdun
country: France
city: Villejuif
country: France
city: Augsburg
country: Germany
city: Bad Honnef
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Butzbach
country: Germany
city: Chemnitz
country: Germany
city: Coesfeld
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Düsseldorf
country: Germany
city: Ebensfeld
country: Germany
city: Frankfurt
country: Germany
city: Fürth
country: Germany
city: Geithain
country: Germany
city: Greifswald
country: Germany
city: Grevenbroich
country: Germany
city: Hamburg
country: Germany
city: Ilmenau
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Köthen
country: Germany
city: Leipzig
country: Germany
city: Limburg
country: Germany
city: Lohne
country: Germany
city: Magdeburg
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Neuss
country: Germany
city: Oranienburg
country: Germany
city: Plauen
country: Germany
city: Potsdam
country: Germany
city: Riesa
country: Germany
city: Schleswig
country: Germany
city: Stolberg
country: Germany
city: Stralsund
country: Germany
city: Ulm
country: Germany
city: Velbert
country: Germany
city: Wetzlar
country: Germany
city: Wismar
country: Germany
city: Wuppertal
country: Germany
city: Arta
country: Greece
city: Athens
country: Greece
city: Chania
country: Greece
city: Crete
country: Greece
city: Ioannina
country: Greece
city: Larisa
country: Greece
city: Thessalonikis
country: Greece
city: Veroia
country: Greece
city: Ekaterinburg
country: Russian Federation
city: Kronshtadt
country: Russian Federation
city: Nizhni Novgorod
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Birmingham
country: South Africa
state: AL
city: Pretoria
country: South Africa
city: Burgos N/A
country: Spain
city: Coruña
country: Spain
city: Getafe
country: Spain
city: Madrid
country: Spain
city: Monforte De Lemos
country: Spain
city: Salamanca
country: Spain
city: Valladolid
country: Spain
city: Vigo
country: Spain
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Erzurum
country: Turkey
city: Eskisehir
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kocaeli
country: Turkey
city: Manisa
country: Turkey
city: Mersin
country: Turkey
city: Trabzon
country: Turkey
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: