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

NCT00294008 | Completed

• 1 other identifier: CR005071
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia; Tranquilizing Agents; Mental Disorders; Therapeutic Uses; Physiological Effects of Drugs; Psychotropic Drugs; Antipsychotic Agents

Keywords

Schizophrenia; Treatment adherence; Antipsychotic agents; Risperidone; Long-acting injectable; Risperdal tablet; Risperidal Consta

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (1)

• employment status, remission, treatment satisfaction, CGI-severity, GAF, clinical deterioration, hospitalization, treatment adherence and (serious) adverse events

  Baseline, 3, 6, 9, 12, 15, 18, 21 and 24-month

Study Arms (1)

001

Risperdal Consta flexible dosage for 24 months

Drug: Risperdal Consta

Interventions

Risperdal Consta DRUG

flexible dosage for 24 months

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Treatment Adherence and Compliance

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 20, 2006
• Study Start: December 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 3, 2014

Record last verified: 2014-04