Schizophrenia Treatment Adherence Investigation (STAI) | NCT01001481

Studies
Schizophrenia Treatment Adherence Investigation (STAI)

NCT01001481

Sponsor

Janssen-Cilag Pty Ltd

Status

Completed

Last Update Posted

Apr 9, 2014Estimated

Enrollment

550Actual

Phase

Not provided

Conditions

Schizophrenia
Schizoaffective Disorder

Interventions

Risk status for medication adherence

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Oct 23, 2009

First Submission Date that Met QC Criteria

Oct 23, 2009

First Posted Date

Oct 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2014

Last Update Posted Date

Apr 9, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

550Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
001			Other: Risk status for medication adherence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risk status for medication adherence	Other	Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia	001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators		6 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical exacerbations (worsening of symptoms)		6 mths, 12 mths
Medication changes		6 mths, 12 mths

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatient clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janssen-Cilag Pty Ltd Clinical Trial	Janssen-Cilag Pty Ltd	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided