Bipolar DisorderPOLARISNCT01663974
Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder
An observational study of Bipolar Disorder and Sub-syndromal Symptoms, run by AstraZeneca at 86 sites in France.
Trial summary
The study aims to evaluate: the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent the functional impact of these disorders, factors or symptom thresholds associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Sub-syndromal Symptoms
- How many people
- 125 participants
- Where
- 86 sitesFrance
- Study dates
- Apr 2013to Dec 2013
- 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: hospital/medico-psychological centre (CMP) [clinic] / private practice
Who may be able to join
- Adult patient with a diagnosis of bipolar disorder according to DSM-IV criteria currently followed up by the investigator in hospital or open-care practice and informed of his/her disease.
- For whom the previous episode was a bipolar depression assessed clinically stabilized for at least 4 weeks by the investigator.
- Able to complete the self-assessment diary weekly
Who cannot join
- Pregnant women.
- Patient included in a clinical trial on an investigational drug or having received an investigational drug in the preceding 30 days.
- Person deprived of freedom or subject to a guardianship (or ward) order or unable to undergo medical monitoring for geographical, social or psychological reasons.
Trial locations and contacts
86 sites in 1 country.
86 sites in 1 country
France86 sites
Research Site
Aix-en-Provence
Research Site
Ajaccio
Research Site
Altkirch
Research Site
Armentières
Research Site
Avignon
Research Site
Bailleul
Research Site
Bohars
Research Site
Bordeaux
Research Site
Bourg-en-Bresse
Research Site
Brest
Research Site
Caen
Research Site
Cahors
Research Site
Castries
Research Site
Challes-les-Eaux
Research Site
Châteaulin
Research Site
Clermont-Ferrand
Research Site
Colmar
Research Site
Conty
Research Site
Coulommiers
Research Site
Créteil
Research Site
Crosne
Research Site
Dax
Research Site
Décines-Charpieu
Research Site
Digne-les-Bains
Research Site
Douai
Research Site
Durtol
Research Site
Dury
Research Site
Fains-Véel
Research Site
Fitz-James
Research Site
Grenoble
Research Site
Hazebrouck
Research Site
Héricourt
Research Site
Issoudun
Research Site
La Roche-sur-Foron
Research Site
La Roche-sur-Yon
Research Site
La Rochelle
Research Site
La Tronche
Research Site
La Varenne-Saint-Hilaire
Research Site
Lamballe
Research Site
Laval
Research Site
Le Mans
Research Site
Le Puy-en-Velay
Research Site
Le Vésinet
Research Site
Libourne
Research Site
Limoges
Research Site
Luynes
Research Site
Lyon
Research Site
Marseille
Research Site
Mayenne
Research Site
Metz
Research Site
Monaco
Research Site
Mont-de-Marsan
Research Site
Montfermeil
Research Site
Montmorency
Research Site
Montpellier
Research Site
Nancy
Research Site
Nemours
Research Site
Nevers
Research Site
Nice
Research Site
Noisiel
Research Site
Novillars
Research Site
Paimpol
Research Site
Paris
Research Site
Pau
Research Site
Reims
Research Site
Rouffach
Research Site
Rueil-Malmaison
Research Site
Saint-Denis
Research Site
Saint-Denis-lès-Bourg
Research Site
Saint-Dizier
Research Site
Saint-Égrève
Research Site
Saint-Nazaire
Research Site
Saint-Vincent-de-Tyrosse
Research Site
Sallanches
Research Site
Sevrey
Research Site
Soissons
Research Site
Sotteville-lès-Rouen
Research Site
Strasbourg
Research Site
Thuir
Research Site
Toulon
Research Site
Toulouse
Research Site
Tours
Research Site
Valence
Research Site
Vernon
Research Site
Versailles
Research Site
Vincennes
About this study
The study aims to evaluate:
- the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
- the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).
Read the detailed description
Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder
- Conditions
- Bipolar Disorder, Sub-syndromal Symptoms
- Keywords
- Bipolar Disorders, Sub-syndromal symptoms, Acute depressive episode, Symptomatic remission, Functioning remission
- 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 |
|---|---|---|
| Bipolar disorder patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire.
The 10 items of the MADRS are scored as 0, 2, 4 and 6 (0 = no depressive symptoms; 6 = severe depressive symptoms). Total scores, ranging from 0 to 60, will be calculated by adding the values for the 10 items. The YMRS scale is composed of 11 items, scored from 0 to 4 (0 = no manic symptoms; 4 = severe manic symptoms). Total scores will be calculated by adding the scores for the 11 items. MVAS-BP questionnaire is composed of 26 visual analogue scales, each item is scored from 0 (extreme depressive pole) to 100 (extreme manic pole). Absence of symptoms is at the middle of the scale (value 50).
Measured: 12 months
Secondary outcomes (3)
Impact of sub-syndromal symptoms on functioning of real-life French Bipolar Disorder patients as measured by scoring on Functioning Assessment Short Test (FAST) scale.
Functioning Assessment Short Test (FAST) is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients. The 24 items of the FAST questionnaire are scored from 0 to 3 (a score of 0 indicates that the patient does not experience any difficulties, while a score of 3 indicates that the patient experiences major difficulties). Total scores will be calculated by adding the scores for each item. Functional remission will be evaluated on the FAST scale ; functional remission will be defined as a score < 11 on the FAST questionnaire.
Measured: 12 months
Number and type of factors associated with a symptomatic and functioning remission after recovery from an acute depressive bipolar episode in real-life French population.
Measured: 12 months
Description of the management patterns (such as number and drug-class of treatments, number and type of resource used) associated with the presence and absence of sub-syndromal symptoms after an acute bipolar depressive episode.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J M AZORIN, Professor, Principal investigator, Hopital Sainte Marguerite - MARSEILLE - FRANCEA SOLVET, Doctor, Study director, AstraZeneca - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663974
- Sponsor's protocol ID
- NIS-NFR-XXX-2012/1
- Acronym
- POLARIS
- Status last verified
- Mar 2015
- First submitted
- 7 Aug 2012
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01663974
- Acronym / sponsor ID
- POLARIS / NIS-NFR-XXX-2012/1
- Conditions
- Bipolar Disorder, Sub-syndromal Symptoms
- Keywords
- Bipolar Disorders, Sub-syndromal symptoms, Acute depressive episode, Symptomatic remission, Functioning remission
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Aug 2012 (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.
The study aims to evaluate:
- the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
- the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).
Detailed description
Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital/medico-psychological centre (CMP) [clinic] / private practice
Key inclusion criteria (3 listed)
- Adult patient with a diagnosis of bipolar disorder according to DSM-IV criteria currently followed up by the investigator in hospital or open-care practice and informed of his/her disease.
- For whom the previous episode was a bipolar depression assessed clinically stabilized for at least 4 weeks by the investigator.
- Able to complete the self-assessment diary weekly
Key exclusion criteria (3 listed)
- Pregnant women.
- Patient included in a clinical trial on an investigational drug or having received an investigational drug in the preceding 30 days.
- Person deprived of freedom or subject to a guardianship (or ward) order or unable to undergo medical monitoring for geographical, social or psychological reasons.
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
The prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire.
Time frame: 12 months
The 10 items of the MADRS are scored as 0, 2, 4 and 6 (0 = no depressive symptoms; 6 = severe depressive symptoms). Total scores, ranging from 0 to 60, will be calculated by adding the values for the 10 items. The YMRS scale is composed of 11 items, scored from 0 to 4 (0 = no manic symptoms; 4 = severe manic symptoms). Total scores will be calculated by adding the scores for the 11 items. MVAS-BP questionnaire is composed of 26 visual analogue scales, each item is scored from 0 (extreme depressive pole) to 100 (extreme manic pole). Absence of symptoms is at the middle of the scale (value 50).
3 secondary outcomes
Impact of sub-syndromal symptoms on functioning of real-life French Bipolar Disorder patients as measured by scoring on Functioning Assessment Short Test (FAST) scale.
Time frame: 12 months
Number and type of factors associated with a symptomatic and functioning remission after recovery from an acute depressive bipolar episode in real-life French population.
Time frame: 12 months
Description of the management patterns (such as number and drug-class of treatments, number and type of resource used) associated with the presence and absence of sub-syndromal symptoms after an acute bipolar depressive episode.
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- NIS-NFR-XXX-2012-1\_Clinical\_Study\_Report\_Synopsis.pdfLink provided by the sponsor.
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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.
J M AZORIN, Professor principal investigator
Hopital Sainte Marguerite - MARSEILLE - FRANCE
A SOLVET, Doctor study director
AstraZeneca - FRANCE
86 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 Sub-syndromal Symptoms, run by AstraZeneca at 86 sites in France.
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 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: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in France. 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 was stopped early. Results are not available in the source record.
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?
The prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire. (time frame: 12 months). 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 9 Mar 2015.