Predictors of Recurrence in Bipolar Disorder in Spain

Bipolar Disorder Clinical Trial

— PREBIS  

Official title:

Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690859
• Other study ID #: NIS-NES-DUM-2007/1
• Status: Completed
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Recurrence

Locations

Country	Name	City	State
Spain	Research Site	Andujar	Jaen
Spain	Research Site	Arganda del Rey	Madrid
Spain	Research Site	Arucas	Las Palmas
Spain	Research Site	Banaderos	Las Palmas
Spain	Research Site	Baracaldo	Vizacaya
Spain	Research Site	Barcelona
Spain	Research Site	Burgos
Spain	Research Site	Calahorra	La Rioja
Spain	Research Site	Conxo	La Coruna
Spain	Research Site	Coria	Caceres
Spain	Research Site	El Ejido	Almeria
Spain	Research Site	Elda	Alicante
Spain	Research Site	Foios	Valencia
Spain	Research Site	Fuenlabrada	Madrid
Spain	Research Site	Gijon	Asturias
Spain	Research Site	Granada
Spain	Research Site	Jaen
Spain	Research Site	Lerida
Spain	Research Site	Madrid
Spain	Research Site	Mairena del Aljarafe	Sevilla
Spain	Research Site	Malaga
Spain	Research Site	Manresa	Barcelona
Spain	Research Site	Murcia
Spain	Research Site	Orense
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Puerto de Sta. Maria	Cadiz
Spain	Research Site	Sabadell	Barcelona
Spain	Research Site	Sagunto	Valencia
Spain	Research Site	Salamanca
Spain	Research Site	Sama De Langreo	Austurias
Spain	Research Site	San Sebastian	Guipuzcoa
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Sevilla
Spain	Research Site	Tenerife
Spain	Research Site	Terrassa	Barcelona
Spain	Research Site	Toro	Zamora
Spain	Research Site	Torrejon de Ardoz	Madrid
Spain	Research Site	Torrevieja	Alicante
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Spain	Research Site	Velez	Malaga
Spain	Research Site	Victoria	Alava
Spain	Research Site	Vigo	Pontevedra
Spain	Research Site	Vilafranca del Penedes	Barcelona
Spain	Research Site	Vilanova	Valencia
Spain	Research Site	Zalla	Vizcaya
Spain	Research Site	Zamudio	Vizcaya
Spain	Research Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period		Every three months
Primary	Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)		Every three months
Secondary	Evaluation of factors that can predict functional outcomes		Every three months
Secondary	Description of Health services utilization (hospitalisations, primary care, treatments..)		Every three months