EMBLEM - European Mania in Bipolar Longitudinal Evaluation of Medication 
Head :
Bellivier Franck, U1144 Variabilité de réponse aux psychotropesÉquipe/activité : Biomarqueurs de la rechute et de la réponse aux traitements dans les addictions et les troubles de l'humeur
Last update : 09/05/2017 | Version : 2 | ID : 21107
| General | |
| Identification | |
| Detailed name | European Mania in Bipolar Longitudinal Evaluation of Medication |
| Sign or acronym | EMBLEM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | --- |
| General Aspects | |
| Medical area |
Psychology and psychiatry |
| Keywords | Social consequences, personality, mood, impact, suicide |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bellivier |
| Surname | Franck |
| Address | 4 Avenue de l'Observatoire Aile 600 - Biologie Cellulaire 75006 PARIS |
| Phone | +33 (0)1 40 05 42 25 |
| frank.bellivier@inserm.fr | |
| Unit | U1144 Variabilité de réponse aux psychotropesÉquipe/activité : Biomarqueurs de la rechute et de la réponse aux traitements dans les addictions et les troubles de l'humeur |
| Organization | Institut national de la santé et de la recherche médicale - |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | - Laboratoires Lilly |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut national de la santé et de la recherche médicale - Inserm |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Patients were recruited by psychiatrists selected from each country involved in the study. |
| Database objective | |
| Main objective | To assess and monitor subjects presenting with a manic or mixed episode of bipolar disorder. |
| Inclusion criteria |
- male and female
- legal age - presenting with bipolar disorder |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | 14 European countries (Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Switzerland, and the UK) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1993 |
| Date of last collection (YYYY or MM/YYYY) | 1995 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 3500 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Sociodemographic information, medical history, suicidal episodes, etc. |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | YMRS (Young Mania Rating Scale) for assessing the patient's degree of bipolarity. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-EMBLEM |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=EMBLEM+AND+Bipolar |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
