Clinical trial NCT00757328: Treatment Clinical Practice in Bipolar Depression in Spain
Official title: EPIDEP. Epidemiologic Study in Bipolar Depression: Evaluation of the Usual Clinical Practice of Psychiatrists in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Depression
Keywords: Bipolar depression Treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

Brief 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


Eligibility 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

Primary outcomes:
measure: Pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line
timeFrame: Last two bipolar episodes recorded in tha patient's clinical history
Secondary outcomes:
measure: Non pharmacological treatments used in Spain by Psychiatrists in the management of bipolar depressive episodes in first and second line
timeFrame: Last two bipolar episodes recorded in tha patient's clinical history
measure: Description of the course of the patients' bipolar disorder
timeFrame: Course of the disorder recorded in the patient's clinical history
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Santiago C.
country: Spain
facility: Research Site
state: La Coruna
city: Palma M
country: Spain
facility: Research Site
state: Mallorca
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Alicante
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Huesca
country: Spain
facility: Research Site
city: Las Palmas
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
Study officials:
References: