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OpenTrials
Completed

NCT Number: NCT00283517

A Registry of Treatment Adherence for Patients With Schizophrenia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antipsychotics

Drug

as prescribed

Primary outcomes

  1. 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.

    Time frame: every 3 months over 2 years

Secondary outcomes

  1. Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study.

    Time frame: every 3 months over 2 years

Sponsors and collaborators

Lead sponsor

Janssen-Cilag, S.A.

Industry

Registry information

Official study title

Electronic Schizophrenia Treatment Adherence Registry, eSTAR

Important dates

Study start
2003
Study completion
2006
First posted
Jan 30, 2006
Registry last updated
Apr 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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