Clinical trial NCT01663974: Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder
Official title: Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bipolar Disorder
Sub-syndromal Symptoms
Keywords: Bipolar Disorders
Sub-syndromal symptoms
Acute depressive episode
Symptomatic remission
Functioning remission
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospital/medico-psychological centre (CMP) \[clinic\] / private practice

Brief 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).

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

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Research Site
city: Ajaccio
country: France
facility: Research Site
city: Altkirch
country: France
facility: Research Site
city: Armentieres
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Bailleul
country: France
facility: Research Site
city: Bohars
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bourg En Bresse
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Cahors
country: France
facility: Research Site
city: Castries
country: France
facility: Research Site
city: Challes Les Eaux
country: France
facility: Research Site
city: Chateaulin
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Conty
country: France
facility: Research Site
city: Coulommiers
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Crosne
country: France
facility: Research Site
city: DAX
country: France
facility: Research Site
city: Decines Charpieu
country: France
facility: Research Site
city: Digne Les Bains
country: France
facility: Research Site
city: Douai
country: France
facility: Research Site
city: Durtol
country: France
facility: Research Site
city: Dury
country: France
facility: Research Site
city: Fains Veel
country: France
facility: Research Site
city: Fitz James
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Hazebrouck
country: France
facility: Research Site
city: Hericourt
country: France
facility: Research Site
city: Issoudun
country: France
facility: Research Site
city: La Roche Sur Foron
country: France
facility: Research Site
city: La Roche Sur Yon
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: La Varenne St Hilaire
country: France
facility: Research Site
city: Lamballe
country: France
facility: Research Site
city: Laval
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Le Puy En Velay
country: France
facility: Research Site
city: Le Vesinet
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Luynes
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mayenne
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Monaco
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Montfermeil
country: France
facility: Research Site
city: Montmorency
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nemours
country: France
facility: Research Site
city: Nevers
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Noisiel
country: France
facility: Research Site
city: Novillars
country: France
facility: Research Site
city: Paimpol
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: PAU
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rouffach
country: France
facility: Research Site
city: Rueil Malmaison
country: France
facility: Research Site
city: Sallanches
country: France
facility: Research Site
city: Sevrey
country: France
facility: Research Site
city: Soissons
country: France
facility: Research Site
city: Sotteville Les Rouen
country: France
facility: Research Site
city: St Denis Les Bourg
country: France
facility: Research Site
city: St Denis
country: France
facility: Research Site
city: St Dizier
country: France
facility: Research Site
city: St Egreve
country: France
facility: Research Site
city: St Nazaire
country: France
facility: Research Site
city: St Vincent de Tyrosse
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Thuir
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Valence
country: France
facility: Research Site
city: Vernon
country: France
facility: Research Site
city: Versailles
country: France
facility: Research Site
city: Vincennes
country: France
facility: Research Site
Study officials:
affiliation: Hopital Sainte Marguerite - MARSEILLE - FRANCE
name: J M AZORIN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca - FRANCE
name: A SOLVET, Doctor
role: STUDY_DIRECTOR
References: