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Schizophrenia Treatment Adherence Investigation (STAI)

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT01001481
First received: October 23, 2009
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention
Schizophrenia
Schizoaffective Disorder
 Other: Risk status for medication adherence

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical exacerbations (worsening of symptoms) [ Time Frame: 6 mths, 12 mths ] [ Designated as safety issue: No ]
  • Medication changes [ Time Frame: 6 mths, 12 mths ] [ Designated as safety issue: No ]

Enrollment: 550
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Other: Risk status for medication adherence
Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001481

Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: Executive Director Medical & Scientific Affairs, Janssen-Cilag Pty Ltd, Australia
ClinicalTrials.gov Identifier: NCT01001481     History of Changes
Other Study ID Numbers: CR013822
Study First Received: October 23, 2009
Last Updated: April 26, 2010
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Treatment review
Schizophrenia
Observational
Prospective studies
Australia

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013