Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder

Bipolar Disorder Clinical Trial

— POLARIS  

Official title:

Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01663974
• Other study ID #: NIS-NFR-XXX-2012/1
• Status: Terminated
• Phase: N/A
• First received: August 7, 2012
• Last updated: March 6, 2015
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Committee on Treatment information for Health and Life Sciences : CCTIRS (Comite Consultatif sur le Traitement de l'Information en matiere de Recherche dans le domaine de la Sante)France : French Data Privacy AuthorityFrance: French Doctors Governing Body
• Study type: Observational

Clinical 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 with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).

Description:

Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Sub-syndromal Symptoms

Locations

Country	Name	City	State
France	Research Site	Aix En Provence
France	Research Site	Ajaccio
France	Research Site	Altkirch
France	Research Site	Armentieres
France	Research Site	Avignon
France	Research Site	Bailleul
France	Research Site	Bohars
France	Research Site	Bordeaux
France	Research Site	Bourg En Bresse
France	Research Site	Brest
France	Research Site	Caen
France	Research Site	Cahors
France	Research Site	Castries
France	Research Site	Challes Les Eaux
France	Research Site	Chateaulin
France	Research Site	Clermont Ferrand
France	Research Site	Colmar
France	Research Site	Conty
France	Research Site	Coulommiers
France	Research Site	Creteil
France	Research Site	Crosne
France	Research Site	DAX
France	Research Site	Decines Charpieu
France	Research Site	Digne Les Bains
France	Research Site	Douai
France	Research Site	Durtol
France	Research Site	Dury
France	Research Site	Fains Veel
France	Research Site	Fitz James
France	Research Site	Grenoble
France	Research Site	Hazebrouck
France	Research Site	Hericourt
France	Research Site	Issoudun
France	Research Site	La Roche Sur Foron
France	Research Site	La Roche Sur Yon
France	Research Site	La Rochelle
France	Research Site	La Tronche
France	Research Site	La Varenne St Hilaire
France	Research Site	Lamballe
France	Research Site	Laval
France	Research Site	Le Mans
France	Research Site	Le Puy En Velay
France	Research Site	Le Vesinet
France	Research Site	Libourne
France	Research Site	Limoges
France	Research Site	Luynes
France	Research Site	Lyon
France	Research Site	Marseille
France	Research Site	Mayenne
France	Research Site	Metz
France	Research Site	Monaco
France	Research Site	Mont de Marsan
France	Research Site	Montfermeil
France	Research Site	Montmorency
France	Research Site	Montpellier
France	Research Site	Nancy
France	Research Site	Nemours
France	Research Site	Nevers
France	Research Site	Nice
France	Research Site	Noisiel
France	Research Site	Novillars
France	Research Site	Paimpol
France	Research Site	Paris
France	Research Site	PAU
France	Research Site	Reims
France	Research Site	Rouffach
France	Research Site	Rueil Malmaison
France	Research Site	Sallanches
France	Research Site	Sevrey
France	Research Site	Soissons
France	Research Site	Sotteville Les Rouen
France	Research Site	St Denis
France	Research Site	St Denis Les Bourg
France	Research Site	St Dizier
France	Research Site	St Egreve
France	Research Site	St Nazaire
France	Research Site	St Vincent de Tyrosse
France	Research Site	Strasbourg
France	Research Site	Thuir
France	Research Site	Toulon
France	Research Site	Toulouse
France	Research Site	Tours
France	Research Site	Valence
France	Research Site	Vernon
France	Research Site	Versailles
France	Research Site	Vincennes

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months	No
Secondary	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.	12 months	No
Secondary	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.		12 months	No
Secondary	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.		12 months	No

External Links

•   NIS-NFR-XXX-2012-1_Clinical_Study_Report_Synopsis.pdf