Bipolar DepressionEPIDEPNCT00757328
Treatment Clinical Practice in Bipolar Depression in Spain
An observational study of Bipolar Depression, run by AstraZeneca at 23 sites in Spain.
Trial summary
Cross-sectional observational, non interventional, multicenter study of retrospective review of clinical records of ambulatory followed up bipolar patients in order to record epidemiological aspects of the course of the disorder, more specifically of bipolar depression episodes and the clinical practices carried out… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Depression
- How many people
- 378 participants
- Where
- 23 sitesSpain
- Study dates
- Jul 2008to Dec 2008
- 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: Adult bipolar I or II patients with no more than 10 years of evolution of the bipolar disorder, with continued assistance in ambulatory settings and whose psychiatrist has recorded the treatment strategy used for of at least 2 depressive episodes within the patients' bipolar condition in the clinical history
Who may be able to join
- Diagnosed of Bipolar Disorder I or II (DSM-IV-TR) in ambulatory follow-up
- Evolution of the bipolar diagnoses inferior to 10 years
- Having recorded in the patient's clinical history the clinical management of at least two bipolar depressive episodes
Who cannot join
- Not having enough information recorded in the clinical history for the essential measurement variables
- To have taken part in other study in the last 6 months
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Spain23 sites
Research Site
Alicante
Research Site
Almería
Research Site
Badajoz
Research Site
Barcelona
Research Site
Bilbao, Vizcaya
Research Site
Cadiz
Research Site
Córdoba
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
Granada
Research Site
Huesca
Research Site
Las Palmas
Research Site
León
Research Site
Madrid
Research Site
Málaga
Research Site
Murcia
Research Site
Oviedo, Principality of Asturias
Research Site
Palma M, Mallorca
Research Site
Pamplona, Navarre
Research Site
Santander, Cantabria
Research Site
Santiago C., La Coruna
Research Site
Seville
Research Site
Valencia
Research Site
Valladolid
About this study
Official title: EPIDEP. Epidemiologic Study in Bipolar Depression: Evaluation of the Usual Clinical Practice of Psychiatrists in Spain
Cross-sectional observational, non interventional, multicenter study of retrospective review of clinical records of ambulatory followed up bipolar patients in order to record epidemiological aspects of the course of the disorder, more specifically of bipolar depression episodes and the clinical practices carried out by psychiatrists in Spain in bipolar depressive episodes
- Conditions
- Bipolar Depression
- Keywords
- Bipolar depression Treatment
- 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 | Ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line
Measured: Last two bipolar episodes recorded in tha patient's clinical history
Secondary outcomes (2)
Non pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line
Measured: Last two bipolar episodes recorded in tha patient's clinical history
Description of the course of the patients' bipolar disorder
Measured: Course of the disorder recorded in the patient's clinical history
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757328
- Sponsor's protocol ID
- NIS-NES-DUM-2008/3
- Acronym
- EPIDEP
- Status last verified
- Feb 2009
- First submitted
- 22 Sep 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIDEP. Epidemiologic Study in Bipolar Depression: Evaluation of the Usual Clinical Practice of Psychiatrists in Spain
- ClinicalTrials.gov ID
- NCT00757328
- Acronym / sponsor ID
- EPIDEP / NIS-NES-DUM-2008/3
- Conditions
- Bipolar Depression
- Keywords
- Bipolar depression Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Sep 2008 (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.
Cross-sectional observational, non interventional, multicenter study of retrospective review of clinical records of ambulatory followed up bipolar patients in order to record epidemiological aspects of the course of the disorder, more specifically of bipolar depression episodes and the clinical practices carried out by psychiatrists in Spain in bipolar depressive episodes
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult bipolar I or II patients with no more than 10 years of evolution of the bipolar disorder, with continued assistance in ambulatory settings and whose psychiatrist has recorded the treatment strategy used for of at least 2 depressive episodes within the patients' bipolar condition in the clinical history
Key inclusion criteria (3 listed)
- Diagnosed of Bipolar Disorder I or II (DSM-IV-TR) in ambulatory follow-up
- Evolution of the bipolar diagnoses inferior to 10 years
- Having recorded in the patient's clinical history the clinical management of at least two bipolar depressive episodes
Key exclusion criteria (2 listed)
- Not having enough information recorded in the clinical history for the essential measurement variables
- To have taken part in other study in the last 6 months
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
Pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line
Time frame: Last two bipolar episodes recorded in tha patient's clinical history
2 secondary outcomes
Non pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line
Time frame: Last two bipolar episodes recorded in tha patient's clinical history
Description of the course of the patients' bipolar disorder
Time frame: Course of the disorder recorded in the patient's clinical history
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 18 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 Depression, run by AstraZeneca at 23 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 2 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 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line (time frame: Last two bipolar episodes recorded in tha patient's clinical history). 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 18 Feb 2009; AzTrials last refreshed its copy on 6 Nov 2026.