Bipolar DisorderNCT01255982
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
An observational study of Bipolar Disorder and Bipolar Depression, run by AstraZeneca at 24 sites in Spain.
Trial summary
This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression
- How many people
- 249 participants
- Where
- 24 sitesSpain
- Study dates
- Mar 2011to Oct 2012
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or II disorder experiencing an acute depressive episode.
Who may be able to join
- Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
- Acute depressive episode at inclusion
Who cannot join
- Inability (in investigator´s opinion) to carry out the follow-up plan
- Patients participating or having participated within previous 6 months, in clinical trials
- Mental retardation or any other medical condition affecting cognitive performance
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites
Research Site
Almería, Almería
Research Site
Barcelona, Barcelona
Research Site
Catarroja, Valencia
Research Site
Córdoba, Cordoba
Research Site
Elche, Alicante
Research Site
Granada, Granada
Research Site
Granollers, Barcelona
Research Site
Langreo, Principality of Asturias
Research Site
Lleida, Lerida
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Monforte de Lemos, Lugo
Research Site
Mos, Pontevedra
Research Site
Ourense, Orense
Research Site
Palencia, Palencia
Research Site
Palma de Mallorca, Palma de Mallorca
Research Site
San Boit de LLobregat, Barcelona
Research Site
Seville, Sevilla
Research Site
Tarragona, Tarragona
Research Site
Tudela, Navarre
Research Site
Valencia, Valencia
Research Site
Villajoyosa, Alicante
Research Site
Zamora, Zamora
Research Site
Zaragoza, Zaragoza
About this study
This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.
- Conditions
- Bipolar Disorder, Bipolar Depression
- Keywords
- Bipolar depression, subsyndromal symptoms, functioning, cognitive function
- 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 | Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
Measured: Range of Days 0-3
Secondary outcomes (4)
FAST score to estimate the proportion of patients that not achieve functional remission
Measured: Range of Days 0-3
Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission
Measured: Range of Days 0-3
Mood chart (self-report)
Measured: Range of Days 0-3
The presence of subsyndromal symptoms after the acute depressive phase using Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR)
Measured: Range of Days 0-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionOct 2012
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255982
- Sponsor's protocol ID
- NIS-NES-DUM-2010/1
- Status last verified
- Oct 2012
- First submitted
- 7 Dec 2010
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
- ClinicalTrials.gov ID
- NCT01255982
- Acronym / sponsor ID
- NIS-NES-DUM-2010/1
- Conditions
- Bipolar Disorder, Bipolar Depression
- Keywords
- Bipolar depression, subsyndromal symptoms, functioning, cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Dec 2010 (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.
This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or II disorder experiencing an acute depressive episode.
Key inclusion criteria (2 listed)
- Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
- Acute depressive episode at inclusion
Key exclusion criteria (3 listed)
- Inability (in investigator´s opinion) to carry out the follow-up plan
- Patients participating or having participated within previous 6 months, in clinical trials
- Mental retardation or any other medical condition affecting cognitive performance
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
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
Time frame: Range of Days 0-3
4 secondary outcomes
FAST score to estimate the proportion of patients that not achieve functional remission
Time frame: Range of Days 0-3
Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission
Time frame: Range of Days 0-3
Mood chart (self-report)
Time frame: Range of Days 0-3
The presence of subsyndromal symptoms after the acute depressive phase using Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR)
Time frame: Range of Days 0-3
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 26 Oct 2012.
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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.
24 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 and Bipolar Depression, run by AstraZeneca at 24 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 2 inclusion and 3 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 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change (time frame: Range of Days 0-3). 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 26 Oct 2012.