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Schizophrenia Treatment Adherence Investigation (STAI)

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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

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 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

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:


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
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT01001481     History of Changes
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:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders