Predictors of Recurrence in Bipolar Disorder in Spain
PREBIS
Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain
1 other identifier
observational
595
1 country
49
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…).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJanuary 22, 2020
May 1, 2009
1.8 years
June 3, 2008
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period
Every three months
Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)
Every three months
Secondary Outcomes (2)
Evaluation of factors that can predict functional outcomes
Every three months
Description of Health services utilization (hospitalisations, primary care, treatments..)
Every three months
Study Arms (1)
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 Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Inability to participate in the study
- To have taken part in other study in the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (49)
Research Site
Victoria, Alava, Spain
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Elda, Alicante, Spain
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Torrevieja, Alicante, Spain
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El Ejido, Almeria, Spain
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Langreo, Austurias, Spain
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Manresa, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Terrassa, Barcelona, Spain
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Vilafranca del Penedès, Barcelona, Spain
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Coria, Caceres, Spain
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El Puerto de Santa María, Cadiz, Spain
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Santander, Cantabria, Spain
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Donostia / San Sebastian, Guipuzcoa, Spain
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Andújar, Jaen, Spain
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Conxo, La Coruna, Spain
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Calahorra, La Rioja, Spain
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Arucas, Las Palmas, Spain
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Banaderos, Las Palmas, Spain
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Arganda, Madrid, Spain
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Fuenlabrada, Madrid, Spain
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Torrejón de Ardoz, Madrid, Spain
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Velez, Malaga, Spain
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Vigo, Pontevedra, Spain
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Gijón, Principality of Asturias, Spain
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Oviedo, Principality of Asturias, Spain
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Mairena del Aljarafe, Sevilla, Spain
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Foios, Valencia, Spain
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Sagunto, Valencia, Spain
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Vilanova, Valencia, Spain
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Barakaldo, Vizacaya, Spain
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Zalla, Vizcaya, Spain
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Zamudio, Vizcaya, Spain
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Toro, Zamora, Spain
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Barcelona, Spain
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Burgos, Spain
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Granada, Spain
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Jaén, Spain
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Lleida, Spain
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Madrid, Spain
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Málaga, Spain
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Murcia, Spain
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Ourense, Spain
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Palma de Mallorca, Spain
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Salamanca, Spain
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Santa Cruz de Tenerife, Spain
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Seville, Spain
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Valencia, Spain
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Valladolid, Spain
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Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 5, 2008
Study Start
June 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
January 22, 2020
Record last verified: 2009-05