Clinical trial NCT00774085: An Observational Study to Assess Treatment & Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone
Official title: Electronic Schizophrenia Treatment Adherence Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal Consta
Propective
Retrospective
Mental disorders
Observational
Lead sponsor: Janssen Cilag N.V./S.A.
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia

Brief summary: The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.

Detailed description: This is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. This is one-country arm of a multinational study. This study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. Usage of risperidone according to label was recommended during the study. The planned recruitment period will be 6 months. Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. Total duration of prospective observation for each patient with a complete follow-up will be 24 months. Data collection during the follow up period will be scheduled every 3 months ± 2 weeks. In addition, this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. Also, this data will provide documentation on switch from oral to parenteral treatment. Data will be pooled from different physicians and/or countries. The objectives of this study are: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.

Eligibility criteria: Inclusion Criteria:

* Patient who started long-acting injectable risperidone treatment after agreement between doctor and patient
* Ambulatory patient or not chronically full-time hospitalized patient. Full-time hospitalization at the moment of inclusion for maximal 6 months
* The treatment and treated indication according to local label
* Patient had given informed consent in agreement with local legislation

Exclusion Criteria:

* Patient participating in another medication related study, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period
* Patient suffering from treatment resistant schizophrenia
* Pregnant or breastfeeding females or females with planned pregnancy within two years

Primary outcomes:
measure: Change in total length of hospitalization from retrospective to prospective period
timeFrame: 48 months
Secondary outcomes:
measure: Change from baseline to 24 months in Clinical Global Impression (CGI) Scale scores
timeFrame: Baseline, (just before the first injection of long-acting injectable risperidone) to 24 months
measure: Change from baseline to 24 months in Global Assessment of Functioning (GAF) scores
timeFrame: Baseline to 24 months
measure: Change from baseline to 24 months in clinical deterioration
timeFrame: Baseline, in 3-monthly intervals (± 2 weeks) for 24 months and Last visit
measure: Change from baseline to 24 months in assessment of remission
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Cilag N.V./S.A.
name: Janssen-Cilag N.V./S.A., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: