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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01001481
Other study ID # CR013822
Secondary ID
Status Completed
Phase Phase 4
First received October 23, 2009
Last updated April 8, 2014
Start date July 2007
Est. completion date September 2009

Study information

Verified date April 2014
Source Janssen-Cilag Pty Ltd
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 550
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Risk status for medication adherence
Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Janssen-Cilag Pty Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators 6 months, 12 months No
Secondary Clinical exacerbations (worsening of symptoms) 6 mths, 12 mths No
Secondary Medication changes 6 mths, 12 mths No
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