A Registry of Treatment Adherence for Patients With Schizophrenia

Sponsor

Janssen-Cilag, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT00283517

Collaborator

(none)

2,046

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Psychotic Disorders	Drug: antipsychotics

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

Study Design

Study Type:

Observational

Actual Enrollment :

2046 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Electronic Schizophrenia Treatment Adherence Registry, eSTAR

Study Start Date :

Sep 1, 2003

Actual Study Completion Date :

May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
001	Drug: antipsychotics as prescribed

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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