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

NCT ID: NCT01663974

Last Updated: 2015-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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

Conditions

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Bipolar Disorder Sub-syndromal Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bipolar disorder patients

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J M AZORIN, Professor

Role: PRINCIPAL_INVESTIGATOR

Hopital Sainte Marguerite - MARSEILLE - FRANCE

A SOLVET, Doctor

Role: STUDY_DIRECTOR

AstraZeneca - FRANCE

Locations

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Aix-en-Provence, , France

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Ajaccio, , France

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Altkirch, , France

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Armentières, , France

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Avignon, , France

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Bailleul, , France

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Bohars, , France

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Bordeaux, , France

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Bourg-en-Bresse, , France

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Brest, , France

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Caen, , France

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Cahors, , France

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Castries, , France

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Challes-les-Eaux, , France

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Châteaulin, , France

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Clermont-Ferrand, , France

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Colmar, , France

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Conty, , France

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Coulommiers, , France

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Créteil, , France

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Crosne, , France

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Dax, , France

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Décines-Charpieu, , France

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Digne-les-Bains, , France

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Douai, , France

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Durtol, , France

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Dury, , France

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Fains-Véel, , France

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Fitz-James, , France

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Grenoble, , France

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Hazebrouck, , France

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Héricourt, , France

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Issoudun, , France

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La Roche-sur-Foron, , France

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La Roche-sur-Yon, , France

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La Rochelle, , France

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La Tronche, , France

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La Varenne-Saint-Hilaire, , France

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Lamballe, , France

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Laval, , France

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Le Mans, , France

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Le Puy-en-Velay, , France

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Le Vésinet, , France

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Libourne, , France

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Limoges, , France

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Luynes, , France

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Lyon, , France

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Marseille, , France

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Mayenne, , France

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Metz, , France

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Monaco, , France

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Mont-de-Marsan, , France

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Montfermeil, , France

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Montmorency, , France

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Montpellier, , France

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Nancy, , France

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Nemours, , France

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Nevers, , France

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Nice, , France

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Noisiel, , France

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Novillars, , France

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Paimpol, , France

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Paris, , France

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Pau, , France

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Reims, , France

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Rouffach, , France

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Rueil-Malmaison, , France

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Saint-Denis, , France

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Saint-Denis-lès-Bourg, , France

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Saint-Dizier, , France

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Saint-Égrève, , France

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Saint-Nazaire, , France

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Saint-Vincent-de-Tyrosse, , France

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Sallanches, , France

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Sevrey, , France

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Soissons, , France

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Sotteville-lès-Rouen, , France

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Strasbourg, , France

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Thuir, , France

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Toulon, , France

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Toulouse, , France

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Tours, , France

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Valence, , France

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Vernon, , France

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Versailles, , France

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Vincennes, , France

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Countries

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France

Related Links

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Other Identifiers

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NIS-NFR-XXX-2012/1

Identifier Type: -

Identifier Source: org_study_id

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