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NCT00757328 Clinical Trial

Treatment Clinical Practice in Bipolar Depression in Spain

Bipolar Depression Clinical Trial

— EPIDEP  

Official title:
EPIDEP. Epidemiologic Study in Bipolar Depression: Evaluation of the Usual Clinical Practice of Psychiatrists in Spain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00757328
Other study ID # NIS-NES-DUM-2008/3
Secondary ID
Status Completed
Phase N/A
First received September 22, 2008
Last updated February 16, 2009
Start date July 2008
Est. completion date December 2008

Study information
Verified date February 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical 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 by psychiatrists in Spain in bipolar depressive episodes

Recruitment information / eligibility
Status Completed
Enrollment 378
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Research Site Alicante
Spain Research Site Almeria
Spain Research Site Badajoz
Spain Research Site Barcelona
Spain Research Site Bilbao Vizcaya
Spain Research Site Cadiz
Spain Research Site Cordoba
Spain Research Site Granada
Spain Research Site Huesca
Spain Research Site Las Palmas
Spain Research Site Leon
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Murcia
Spain Research Site Oviedo Asturias
Spain Research Site Palma M Mallorca
Spain Research Site Pamplona Navarra
Spain Research Site San Sebastian Guipuzcoa
Spain Research Site Santander Cantabria
Spain Research Site Santiago C. La Coruna
Spain Research Site Sevilla
Spain Research Site Valencia
Spain Research Site Valladolid

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line Last two bipolar episodes recorded in tha patient's clinical history
Secondary Non pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line Last two bipolar episodes recorded in tha patient's clinical history
Secondary Description of the course of the patients' bipolar disorder Course of the disorder recorded in the patient's clinical history
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