NCT00927420

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

24 active sites

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

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

First QC Date

June 23, 2009

Last Update Submit

October 29, 2009

Conditions

Keywords

Bipolar disorderadherencetreatmentreal life practice

Outcome Measures

Primary Outcomes (2)

  • Morisky-Green Scale

    Once, at the visit moment

  • Drug Attitude Inventory Scale (DAI-10)

    Once, at the visit moment

Secondary Outcomes (2)

  • Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M)

    Once, at the visit moment

  • Functioning Assessment Short Test (FAST)

    Once, at the visit moment

Study Arms (1)

1

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Patients participating in clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

Las Palmas, Gran Canarias, Spain

Location

Research Site

Calahorra, La Rioja, Spain

Location

Research Site

Langreo, Principality of Asturias, Spain

Location

Research Site

San Cristóbal de La Laguna, Tenerife, Spain

Location

Research Site

Alicante, Spain

Location

Research Site

Almería, Spain

Location

Research Site

Badajoz, Spain

Location

Research Site

Barcelona, Spain

Location

Research Site

Córdoba, Spain

Location

Research Site

Elche, Spain

Location

Research Site

León, Spain

Location

Research Site

Lleida, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Murcia, Spain

Location

Research Site

Ourense, Spain

Location

Research Site

Palma de Mallorca, Spain

Location

Research Site

Salamanca, Spain

Location

Research Site

Seville, Spain

Location

Research Site

Toledo, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Valladolid, Spain

Location

Research Site

Vitoria-Gasteiz, Spain

Location

Research Site

Zaragoza, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Elisa Gil

    AstraZeneca Spain EpidemiologyValue Demonstration Unit

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

July 1, 2009

Study Completion

October 1, 2009

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations