Bipolar DisorderNCT00927420
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
An observational study of Bipolar Disorder, run by AstraZeneca at 24 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 24 sitesSpain
- Study dates
- Jul 2009to Oct 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: Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings
Who may be able to join
- Patients diagnosed with bipolar disorder I or II DSM-IV
- Patients treated with at least one oral antipsychotic
- Subjects able to read and write
Who cannot join
- Patients participating in clinical trials
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites
Research Site
Alicante
Research Site
Almería
Research Site
Badajoz
Research Site
Barcelona
Research Site
Calahorra, La Rioja
Research Site
Córdoba
Research Site
Elche
Research Site
Langreo, Principality of Asturias
Research Site
Las Palmas, Gran Canarias
Research Site
León
Research Site
Lleida
Research Site
Madrid
Research Site
Málaga
Research Site
Murcia
Research Site
Ourense
Research Site
Palma de Mallorca
Research Site
Salamanca
Research Site
San Cristóbal de La Laguna, Tenerife
Research Site
Seville
Research Site
Toledo
Research Site
Valencia
Research Site
Valladolid
Research Site
Vitoria-Gasteiz
Research Site
Zaragoza
About this study
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.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, adherence, treatment, real life practice
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky-Green Scale
Measured: Once, at the visit moment
Drug Attitude Inventory Scale (DAI-10)
Measured: Once, at the visit moment
Secondary outcomes (2)
Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M)
Measured: Once, at the visit moment
Functioning Assessment Short Test (FAST)
Measured: Once, at the visit moment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elisa Gil, Study director, AstraZeneca Spain EpidemiologyValue Demonstration Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927420
- Sponsor's protocol ID
- NIS-NES-DUM-2009/1
- Status last verified
- Oct 2009
- First submitted
- 23 Jun 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
- ClinicalTrials.gov ID
- NCT00927420
- Acronym / sponsor ID
- NIS-NES-DUM-2009/1
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, adherence, treatment, real life practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Jun 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 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings
Key inclusion criteria (3 listed)
- Patients diagnosed with bipolar disorder I or II DSM-IV
- Patients treated with at least one oral antipsychotic
- Subjects able to read and write
Key exclusion criteria (1 listed)
- Patients participating in clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morisky-Green Scale
Time frame: Once, at the visit moment
Drug Attitude Inventory Scale (DAI-10)
Time frame: Once, at the visit moment
2 secondary outcomes
Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M)
Time frame: Once, at the visit moment
Functioning Assessment Short Test (FAST)
Time frame: Once, at the visit moment
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 30 Oct 2009.
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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.
Elisa Gil study director
AstraZeneca Spain EpidemiologyValue Demonstration Unit
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by AstraZeneca at 24 sites in Spain.
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 3 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 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Morisky-Green Scale (time frame: Once, at the visit moment). The study lists 2 primary outcomes in all. 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 30 Oct 2009.