Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00927420

First received: June 23, 2009

Last updated: October 29, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2009

Last Updated Date

October 29, 2009

Start Date ^ICMJE

July 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Morisky-Green Scale [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]
Drug Attitude Inventory Scale (DAI-10) [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00927420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M) [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]
Functioning Assessment Short Test (FAST) [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

Official Title ^ICMJE

Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

Brief Summary

The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

300

Completion Date

October 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients diagnosed with bipolar disorder I or II DSM-IV
Patients treated with at least one oral antipsychotic
Subjects able to read and write

Exclusion Criteria:

Patients participating in clinical trials

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00927420

Other Study ID Numbers ^ICMJE

NIS-NES-DUM-2009/1

Has Data Monitoring Committee

Responsible Party

MC MD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Elisa Gil

AstraZeneca Spain EpidemiologyValue Demonstration Unit

Information Provided By

AstraZeneca

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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