Bipolar DisorderPREBISNCT00690859
Predictors of Recurrence in Bipolar Disorder in Spain
An observational study of Bipolar Disorder, run by AstraZeneca at 49 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 595 participants
- Where
- 49 sitesSpain
- Study dates
- Jun 2007to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to participate in the study
- To have taken part in other study in the last 6 months
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
Spain49 sites
Research Site
Andújar, Jaen
Research Site
Arganda, Madrid
Research Site
Arucas, Las Palmas
Research Site
Banaderos, Las Palmas
Research Site
Barakaldo, Vizacaya
Research Site
Barcelona
Research Site
Burgos
Research Site
Calahorra, La Rioja
Research Site
Conxo, La Coruna
Research Site
Coria, Caceres
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
El Ejido, Almeria
Research Site
El Puerto de Santa María, Cadiz
Research Site
Elda, Alicante
Research Site
Foios, Valencia
Research Site
Fuenlabrada, Madrid
Research Site
Gijón, Principality of Asturias
Research Site
Granada
Research Site
Jaén
Research Site
Langreo, Austurias
Research Site
Lleida
Research Site
Madrid
Research Site
Mairena del Aljarafe, Sevilla
Research Site
Málaga
Research Site
Manresa, Barcelona
Research Site
Murcia
Research Site
Ourense
Research Site
Oviedo, Principality of Asturias
Research Site
Palma de Mallorca
Research Site
Sabadell, Barcelona
Research Site
Sagunto, Valencia
Research Site
Salamanca
Research Site
Santa Cruz de Tenerife
Research Site
Santander, Cantabria
Research Site
Seville
Research Site
Terrassa, Barcelona
Research Site
Toro, Zamora
Research Site
Torrejón de Ardoz, Madrid
Research Site
Torrevieja, Alicante
Research Site
Valencia
Research Site
Valladolid
Research Site
Velez, Malaga
Research Site
Victoria, Alava
Research Site
Vigo, Pontevedra
Research Site
Vilafranca del Penedès, Barcelona
Research Site
Vilanova, Valencia
Research Site
Zalla, Vizcaya
Research Site
Zamudio, Vizcaya
Research Site
Zaragoza
About this study
Official title: 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
- to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality
- to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms
- 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
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorders, Predictors of recurrence
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period
Measured: Every three months
Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)
Measured: Every three months
Secondary outcomes (2)
Evaluation of factors that can predict functional outcomes
Measured: Every three months
Description of Health services utilization (hospitalisations, primary care, treatments..)
Measured: Every three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690859
- Sponsor's protocol ID
- NIS-NES-DUM-2007/1
- Acronym
- PREBIS
- Status last verified
- May 2009
- First submitted
- 3 Jun 2008
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain
- ClinicalTrials.gov ID
- NCT00690859
- Acronym / sponsor ID
- PREBIS / NIS-NES-DUM-2007/1
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorders, Predictors of recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality
- to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to participate in the study
- To have taken part in other study in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period
Time frame: Every three months
Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)
Time frame: Every three months
2 secondary outcomes
Evaluation of factors that can predict functional outcomes
Time frame: Every three months
Description of Health services utilization (hospitalisations, primary care, treatments..)
Time frame: Every three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by AstraZeneca at 49 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period (time frame: Every three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.