SchizophreniaNCT01001481
Schizophrenia Treatment Adherence Investigation (STAI)
An observational study of Schizophrenia and Schizoaffective Disorder, run by Janssen-Cilag Pty Ltd.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Risk status for medication adherence
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinics
Who may be able to join
- 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
Who cannot join
- N/A
About this study
Official title: Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia
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.
Read the 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
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Risk status for medication adherence
- Keywords
- Treatment review, Schizophrenia, Observational, Prospective studies, Australia
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk status for medication adherenceOther
Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Risk status for medication adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators
Measured: 6 months, 12 months
Secondary outcomes (2)
Clinical exacerbations (worsening of symptoms)
Measured: 6 mths, 12 mths
Medication changes
Measured: 6 mths, 12 mths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Pty Ltd Clinical Trial, Study director, Janssen-Cilag Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001481
- Sponsor's protocol ID
- CR013822
- Status last verified
- Apr 2014
- First submitted
- 23 Oct 2009
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia
- ClinicalTrials.gov ID
- NCT01001481
- Acronym / sponsor ID
- CR013822
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Treatment review, Schizophrenia, Observational, Prospective studies, Australia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Janssen-Cilag Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Risk status for medication adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinics
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk status for medication adherenceExamination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia | Other | 001 |
Primary outcome
Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators
Time frame: 6 months, 12 months
2 secondary outcomes
Clinical exacerbations (worsening of symptoms)
Time frame: 6 mths, 12 mths
Medication changes
Time frame: 6 mths, 12 mths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Pty Ltd Clinical Trial study director
Janssen-Cilag Pty Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Janssen-Cilag Pty Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators (time frame: 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.