Schizophrenia Treatment Adherence Investigation (STAI)

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Other: Risk status for medication adherence

• Registration Number: NCT01001481
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Risk status for medication adherence	-

Primary Outcome Measures

Name	Time	Method
Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators	6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Clinical exacerbations (worsening of symptoms)	6 mths, 12 mths
Medication changes	6 mths, 12 mths