- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283517
A Registry of Treatment Adherence for Patients With Schizophrenia
April 26, 2010 updated by: Janssen-Cilag, S.A.
Electronic Schizophrenia Treatment Adherence Registry, eSTAR
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
2046
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local area; permitted by their physician to participate in a clinical trial
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
001
|
as prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time 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.
Time Frame: every 3 months over 2 years
|
every 3 months over 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
every 3 months over 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
January 27, 2006
First Submitted That Met QC Criteria
January 27, 2006
First Posted (Estimate)
January 30, 2006
Study Record Updates
Last Update Posted (Estimate)
April 27, 2010
Last Update Submitted That Met QC Criteria
April 26, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005548
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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