Last update : 08/05/2015 | Version : 2 | ID : 7196
| General | |
| Identification | |
| Detailed name | International Longitudinal Study on The Treatment of Somatoform Disorders with Sulpiride |
| Sign or acronym | SOMA-D |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | -- |
| General Aspects | |
| Medical area |
Neurology Psychology and psychiatry |
| Health determinants |
Medicine |
| Keywords | sulpiride, Europe, incidence |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rouillon |
| Surname | Frederic |
| Address | 40 rue de Mesly, 94000 Créteil |
| Phone | +33 (0)1 45 65 77 31 |
| F.ROUILLON@ch-sainte-anne.fr | |
| Unit | U894 Centre de psychiatrie et neurosciencesÉquipe/activité: Analyse phénotype, développementale et génétique des comportements addictifs |
| Organization | CHU Albert |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | UHC (CHU) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Albert Chenevier |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | The sample consists of patients that are recruited by general practitioners, psychiatrists, neuropsychiatrists and internists. |
| Database objective | |
| Main objective | To demonstrate the effects of sulpiride in patients with a somatoform disorder. |
| Inclusion criteria |
- Male or female;
- Adult; - Responding to sulpiride treatment. |
| 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 | Germany, Belgium, Spain, France, Portugal. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2001 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1356 - 515: Germany - 260: Belgium - 395: Spain - 77: France - 109: Portugal |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Questionnaire on patient somatic and psychological symptoms. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Data are collected using the Clinical Global Impression (CGI) scale and the 58-item Hopkins Symptom Checklist (SCL-58). |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-SOMA-D |
| 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 |
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