A Registry of Treatment Adherence for Patients With Schizophrenia

Status Completed

Clinical Trial 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.

Clinical Trial 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00283517
Study type	Observational
Source	Janssen-Cilag, S.A.
Contact
Status	Completed
Phase	N/A
Start date	September 2003
Completion date	May 2006

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.