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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01026285
• Date of registration: 03/12/2009
• Prospective Registration: No
• Primary sponsor: Janssen-Cilag International NV
• Public title: InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics
• Scientific 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
• Date of first enrolment: June 2009
• Target sample size: 1085
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01026285
• Study type: Observational
• Study design: Time Perspective: Prospective

Countries of recruitment

Czech Republic, France, Germany, Greece, Russian Federation, South Africa, Spain, Turkey, United States

Contacts

• Name: Janssen-Cilag International NV Clinical Trial
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Risperidone Long-Acting injectable or oral antipsychotics

Primary Outcome(s)

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(s)

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]

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 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]

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]

Secondary ID(s)

CR016630

RISSCH4230

Source(s) of Monetary Support

Please refer to primary and secondary sponsors