NCT01001481

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2009

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

October 23, 2009

Last Update Submit

April 8, 2014

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

Treatment reviewSchizophreniaObservationalProspective studiesAustralia

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators

    6 months, 12 months

Secondary Outcomes (2)

  • Clinical exacerbations (worsening of symptoms)

    6 mths, 12 mths

  • Medication changes

    6 mths, 12 mths

Study Arms (1)

001

Other: Risk status for medication adherence

Interventions

Risk status for medication adherenceOTHER

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

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinics

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Janssen-Cilag Pty Ltd Clinical Trial

    Janssen-Cilag Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 26, 2009

Study Start

July 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 9, 2014

Record last verified: 2014-04