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A Registry of Treatment Adherence for Patients With Schizophrenia

Electronic Schizophrenia Treatment Adherence Registry, eSTAR

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00283517
Enrollment
2046
Registered
2006-01-30
Start date
2003-09-30
Completion date
2006-05-31
Last updated
2010-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Psychotic Disorders

Keywords

Risperidone long-acting injection, Antipsychotic medication, Schizophrenia, Treatment retention, Observational study

Brief summary

The purpose of the study is to assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotic medications.

Detailed description

Recent studies have suggested the superior effectiveness of second generation (atypical) antipsychotic medications over first generation (conventional) antipsychotics in preventing relapse during the treatment of schizophrenia. It is estimated that a majority of patients with schizophrenia have difficulty adhering to the daily regimen of oral medications, and the use of long-acting injectable antipsychotics has been shown to increase compliance. This study includes both retrospective and prospective observations of the treatments and outcomes associated with antipsychotic drug therapy as well as characteristics of the patient population. The study is not product specific and includes patients using therapy with long-acting injectable, tablet, or liquid formulations of conventional or atypical antipsychotic medications. All patients who enroll in the study start treatment with a new antipsychotic medication, which is to be used according to the product labeling in the local country. Retrospective data, collected over a minimum of 12 months, include patient diagnosis, age, sex, history of treatment with antipsychotic medications, hospitalization, Clinical Global Impression of severity of disease (CGI-severity), Global Assessment of Functioning (GAF), and the reason for starting a new antipsychotic treatment. Prospective data, collected every 3 months over 2 years, are evaluated to assess the effectiveness of treatment and include the patient's adherence to antipsychotic medication, CGI-severity, GAF, and clinical deterioration of the patient's condition. The study investigator enters the data into a registry either electronically or on paper record forms. Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study. Atypical or conventional antipsychotics, as tablet, liquid or injectable formulations as prescribed

Interventions

as prescribed

Sponsors

Janssen-Cilag, S.A.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local country * Permitted by their physician and by the patient to participate in a clinical trial

Exclusion criteria

* Patients not meeting all of the inclusion criteria for entry into the study

Design outcomes

Primary

MeasureTime frame
To assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotics medications.every 3 months over 2 years

Secondary

MeasureTime frame
Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study.every 3 months over 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026