Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
595 participants
OBSERVATIONAL
2007-06-30
2009-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* To have taken part in other study in the last 6 months
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Locations
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Research Site
Victoria, Alava, Spain
Research Site
Elda, Alicante, Spain
Research Site
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
Research Site
Valladolid, , Spain
Research Site
Zaragoza, , Spain
Countries
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Other Identifiers
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NIS-NES-DUM-2007/1
Identifier Type: -
Identifier Source: org_study_id
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