Treatment Clinical Practice in Bipolar Depression in Spain (EPIDEP)

February 16, 2009 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Research Site
      • Almeria, Spain
        • Research Site
      • Badajoz, Spain
        • Research Site
      • Barcelona, 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
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain
        • Research Site
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain
        • Research Site
    • La Coruna
      • Santiago C., La Coruna, Spain
        • Research Site
    • Mallorca
      • Palma M, Mallorca, Spain
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Last two bipolar episodes recorded in tha patient's clinical history

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Course of the disorder recorded in the patient's clinical history

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NES-DUM-2008/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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