Treatment Clinical Practice in Bipolar Depression in Spain (EPIDEP)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00757328
First received: September 22, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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


Condition
Bipolar Depression

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: EPIDEP. Epidemiologic Study in Bipolar Depression: Evaluation of the Usual Clinical Practice of Psychiatrists in Spain

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 378
Study Start Date: July 2008
Study Completion Date: December 2008
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757328

Locations
Spain
Research Site
Oviedo, Asturias, Spain
Research Site
Santander, Cantabria, Spain
Research Site
San Sebastian, Guipuzcoa, Spain
Research Site
Santiago C., La Coruna, Spain
Research Site
Palma M, Mallorca, Spain
Research Site
Pamplona, Navarra, Spain
Research Site
Bilbao, Vizcaya, Spain
Research Site
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
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00757328     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2008/3
Study First Received: September 22, 2008
Last Updated: February 16, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Bipolar depression Treatment

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014