Predictors of Recurrence in Bipolar Disorder in Spain (PREBIS)

January 21, 2020 updated by: AstraZeneca

Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

595

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period
Time Frame: Every three months
Every three months
Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)
Time Frame: Every three months
Every three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of factors that can predict functional outcomes
Time Frame: Every three months
Every three months
Description of Health services utilization (hospitalisations, primary care, treatments..)
Time Frame: Every three months
Every three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (ESTIMATE)

June 5, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NES-DUM-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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