Clinical trial NCT00690859: Predictors of Recurrence in Bipolar Disorder in Spain
Official title: Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar disorders
Predictors of recurrence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Observational, prospective (1 year follow up), multicenter, non-interventional open label study in order to assess the factors that predict onset of mood disorders episodes (depression, mania, hypomania and mixed) in stabilized patients with bipolar disorder I or II in Spain. Other objectives are

1. to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality
2. to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms
3. to evaluate the economical impact on health service of these patients (hospitalization, primary care, treatments...).

Target population is 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. The primary endpoint is the onset of mood disorders episodes (depression, mania, hypomania and mixed) during the follow-up period and evaluation of which factors predict onset of mood episodes


Eligibility criteria: Inclusion Criteria:

* Diagnosed of Bipolar Disorder I or II (DSM-IV-TR)
* Patients Stabilized from at least 2 months who had a mood disorder episode (depression, mania, hypomania or mixed) in the last year.
* To be attended by a psychiatric specialist

Exclusion Criteria:

* Inability to participate in the study
* To have taken part in other study in the last 6 months

Primary outcomes:
measure: Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period
timeFrame: Every three months
measure: Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)
timeFrame: Every three months
Secondary outcomes:
measure: Evaluation of factors that can predict functional outcomes
timeFrame: Every three months
measure: Description of Health services utilization (hospitalisations, primary care, treatments..)
timeFrame: Every three months
Other outcomes:
Locations:
city: Victoria
country: Spain
facility: Research Site
state: Alava
city: Elda
country: Spain
facility: Research Site
state: Alicante
city: Torrevieja
country: Spain
facility: Research Site
state: Alicante
city: El Ejido
country: Spain
facility: Research Site
state: Almeria
city: Gijon
country: Spain
facility: Research Site
state: Asturias
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Sama De Langreo
country: Spain
facility: Research Site
state: Austurias
city: Manresa
country: Spain
facility: Research Site
state: Barcelona
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Terrassa
country: Spain
facility: Research Site
state: Barcelona
city: Vilafranca del Penedes
country: Spain
facility: Research Site
state: Barcelona
city: Coria
country: Spain
facility: Research Site
state: Caceres
city: Puerto de Sta. Maria
country: Spain
facility: Research Site
state: Cadiz
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Andujar
country: Spain
facility: Research Site
state: Jaen
city: Conxo
country: Spain
facility: Research Site
state: La Coruna
city: Calahorra
country: Spain
facility: Research Site
state: La Rioja
city: Arucas
country: Spain
facility: Research Site
state: Las Palmas
city: Banaderos
country: Spain
facility: Research Site
state: Las Palmas
city: Arganda del Rey
country: Spain
facility: Research Site
state: Madrid
city: Fuenlabrada
country: Spain
facility: Research Site
state: Madrid
city: Torrejon de Ardoz
country: Spain
facility: Research Site
state: Madrid
city: Velez
country: Spain
facility: Research Site
state: Malaga
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Mairena del Aljarafe
country: Spain
facility: Research Site
state: Sevilla
city: Foios
country: Spain
facility: Research Site
state: Valencia
city: Sagunto
country: Spain
facility: Research Site
state: Valencia
city: Vilanova
country: Spain
facility: Research Site
state: Valencia
city: Baracaldo
country: Spain
facility: Research Site
state: Vizacaya
city: Zalla
country: Spain
facility: Research Site
state: Vizcaya
city: Zamudio
country: Spain
facility: Research Site
state: Vizcaya
city: Toro
country: Spain
facility: Research Site
state: Zamora
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Lerida
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: Orense
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tenerife
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: