A Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres (e-STAR)
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Tranquilizing Agents; Mental Disorders; Therapeutic Uses; Physiological Effects of Drugs; Psychotropic Drugs; Antipsychotic Agents
Intervention: Risperdal Consta (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.
Summary
This study is a non-interventional web based registry designed to assess demographic,
treatment and outcomes data in patients receiving treatment with long-acting injectable
risperidone. One year retrospective data and 2 year prospective data will be collected.
Clinical Details
Official title: Electronic Schizophrenia Treatment Adherence Registry(e-STAR): An Observational, International Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres
Study design: Observational Model: Case-Only
Primary outcome: The primary endpoint is the the number of days spent in hospital during the first year with Risperdal Consta compared with the year before Risperdal Consta.
Secondary outcome: employment status, remission, treatment satisfaction, CGI-severity, GAF, clinical deterioration, hospitalization, treatment adherence and (serious) adverse events
Detailed description:
This study is a multicentre, retrospective and prospective observational, cohort design,
determining aggregate drug usage patterns and commonly used clinical outcomes associated
with the use of long-acting injectable risperidone. The objectives of this study are to
collect sufficient retrospective outcome data to allow the evaluation of treatment outcomes
with long acting medication compared to previous treatments and to document clinical
effectiveness and long-term treatment outcomes in actual practice. Additional objectives
are to prospectively assess medication usage patterns and to evaluate reasons for initiation
and/or discontinuation of new antipsychotic medications. The study design is a
non-interventional, single-arm, observational survey on the use of long-acting injectable
risperidone and other long-acting (depot) or oral atypical antipsychotics, with the aim to
assess patient outcomes by existing risk or disease factors, patient characteristics, or
previous medication. Having reached agreement with the patient on starting treatment with
long-acting injectable risperidone, physicians have the opportunity to document the
patient's clinical data in the Registry. At baseline, data will be collected
retrospectively over a minimum period of 12-months per patient. Data will be collected
prospectively over a 24-month period per patient at approximately 3-month intervals after
starting treatment. This study will document data of patients for whom treatment with the
new antipsychotic medication is indicated, and who are being treated according to the local
label. The start date for collecting data is the date the new antipsychotic treatment is
initiated, whether as inpatient or outpatient. The preceding 12 months and the next 2 years
are respectively for each patient the retrospective and prospective periods of interest.
All patients starting with a new antipsychotic medication, decided after agreement between
the physician and the patient, in accordance with the local label, are eligible for
inclusion in this survey. While patients participating in randomized clinical trials are
not excluded, their participation will be noted. Data will be entered by the treating
physician. All data collected must be the result of the normal medical care of the patient.
No intervention on treatment decisions permitted. The patient's baseline data will be
collected within the first week following initiation of the new antipsychotic treatment.
Prospective data collection has to occur 3 months, 6 months, 9 months, 12 months, 15 months,
18 months, 21 months and 24 months after initiation of the new antipsychotic treatment. If a
patient stops the newly initiated antipsychotic treatment the reason for discontinuation has
to be reported. Patients discontinuing newly initiated antipsychotic treatment will continue
to be followed for up to 24 months. In retrospective period the following treatment
outcomes will be assessed: patient characteristics, treatment history with antipsychotics
and other concomitant medication, hospitalization history, reason for initiating the new
antipsychotic treatment, treatment satisfaction, remission, clinical global impression
(CGI-severity), global assessment of functioning (GAF) and clinical deterioration. In
prospective period clinical effectiveness will be assessing the following: employment
status, remission, treatment satisfaction, CGI-severity, GAF, clinical deterioration,
hospitalization, treatment adherence and (serious) adverse events. Long-acting injectable
risperidone is flexible dose (25mg to 75mg), intramuscular injection given into gluteus for
24 months
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients starting treatment with a new antipsychotic medication
- Permitted by their physician to participate in a clinical trial
- Patients with schizophrenia or schizoaffective disorder
- Patients who are an ambulant or not chronically hospitalized for maximal 6 months at
the moment of initiation of study
- Patients and/or his/her relative, guardian or legal representative has signed the
informed consent form
Exclusion Criteria:
- First antipsychotic treatment ever
- Participating in any other drug study
- Chronically hospitalized and according to physician no possibility of being
discharged within the planned observation period
- On clozapine during the last 3 months
- Serious unstable medical condition, including recent and present clinically relevant
laboratory abnormalities
- Previous sensitivity history to risperidone and treatment resistant schizophrenia
- Pregnant or breast-feeding female
- Female with planned pregnancy within two years
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: April 2, 2014
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