A Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres (e-STAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00294008
First received: February 16, 2006
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Antipsychotic Agents
Drug: Risperdal Consta
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Electronic Schizophrenia Treatment Adherence Registry(e-STAR): An Observational, International Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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. [ Time Frame: Outcome measure is assessed prospectively over a 24-month period per patient at approximately 3-month intervals after starting treatment. Assessment points are baseline, 3, 6, 9, 12, 15, 18, 21, 24-month. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • employment status, remission, treatment satisfaction, CGI-severity, GAF, clinical deterioration, hospitalization, treatment adherence and (serious) adverse events [ Time Frame: Baseline, 3, 6, 9, 12, 15, 18, 21 and 24-month ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: December 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Risperdal Consta flexible dosage for 24 months
Drug: Risperdal Consta
flexible dosage for 24 months

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294008

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00294008     History of Changes
Other Study ID Numbers: CR005071
Study First Received: February 16, 2006
Last Updated: April 2, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Schizophrenia
Treatment adherence
Antipsychotic agents
Risperidone
Long-acting injectable
Risperdal tablet
Risperidal Consta

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 20, 2014