Last update : 09/05/2017 | Version : 1 | ID : 73154
General | |
Identification | |
Detailed name | Cohort of Schizophrenic Patients Receiving Antipsychotic Drugs |
Sign or acronym | SOHO-France |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
General Aspects | |
Medical area |
Disability/handicap Psychology and psychiatry |
Pathology (details) | Schizophrenia |
Health determinants |
Genetic Iatrogenic Lifestyle and behavior Medicine |
Keywords | antipsychotic, remission, schizophrenia, relapse, treatment |
Scientific investigator(s) (Contact) | |
Name of the director | Gasquet |
Surname | Isabelle |
Phone | +33 (0)1 40 27 31 85 |
isabelle.gasquet@pbr.ap-hop-paris.fr | |
Organization | Paris Public Hospitals |
Collaborations | |
Funding | |
Funding status |
Private |
Details | Lilly France pharmaceutical laboratory |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Assistance publique–hôpitaux de Paris |
Organisation status |
Public |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health care professionals |
Database recruitment is is made on the basis of: |
Medication(s) taken |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Patients were recruited by psychiatrists drawn from the LOGIMED (IMS Health) and TVF (CEGEDIM) sampling frame with layering according to activity type (private versus hospital practice or mixed) and area of practice. Each psychiatrist must recruit four patients consecutively: two patients receiving olanzapine and two patients receiving an anti-psychotic prescribed at the discretion of the treating psychiatrist from available treatment (risperidone, amisulpride, clozapine, typical oral antipsychotics and intramuscular, long-acting medication). |
Database objective | |
Main objective | To provide information on patients monitored as outpatients, regardless of antipsychotic treatment received and to provide answers, especially regarding treatment adherence and remission rates, as well as relapse rates over a three-year monitoring period. |
Inclusion criteria | Schizophrenic adult patients monitored as outpatients and randomly recruited by psychiatrists. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
Population covered |
Sick population |
Gender |
Male Woman |
Geography area |
National |
Detail of the geography area | France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2001 |
Date of last collection (YYYY or MM/YYYY) | 2005 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 964 |
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 | History of illness, previous and ongoing treatments, symptomatology (Clinical Global Impression – Schizophrenia [CGI-SCH] scale) and a Visual Analogue Scale [VAS]). Clinical severity was measured by the CGI-SCH scale. |
Declarative data (detail) |
Face to face interview |
Details of collected declarative data | Demographic data, quality of life (EuroQol scale of five items [EQ-5D]; addictive comorbidities in the form of simple questions on past and current use of illicit substances and alcohol; social status (accommodation type, type of work activity, number of social activities, etc.) |
Presence of a biobank |
No |
Health parameters studied |
Health care consumption and services |
Care consumption (detail) |
Medicines consumption |
Procedures | |
Participant monitoring |
Yes |
Details on monitoring of participants | Follow-up at three and six months then every six months for three years. |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/19162420 |
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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