Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Schizophrenia Treatment Adherence Investigation (STAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001481
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia.

Condition or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Other: Risk status for medication adherence

Detailed Description:
The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia. Observational study - no study drug administered
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia
Study Start Date : July 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
001 Other: Risk status for medication adherence
Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators [ Time Frame: 6 months, 12 months ]

Secondary Outcome Measures :
  1. Clinical exacerbations (worsening of symptoms) [ Time Frame: 6 mths, 12 mths ]
  2. Medication changes [ Time Frame: 6 mths, 12 mths ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient clinics
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV
  • Currently treated in an outpatient clinic
  • Able to provide informed consent
  • Concurrent enrolment in clinical trials is acceptable
  • Have completed all questions on the Drug Attitude Inventory (DAI-10) and Medication Adherence Rating Scale (MARS) survey

Exclusion Criteria:

  • N/A
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001481


Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Layout table for investigator information
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT01001481    
Other Study ID Numbers: CR013822
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Janssen-Cilag Pty Ltd:
Treatment review
Schizophrenia
Observational
Prospective studies
Australia
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders