Status: FinalisedLast updated on: 16/09/2019
1. Study identification
EU PAS Register NumberEUPAS20778
Official titleResistant Depression in France, description from the nationwide claims and hospitalization database
Study title acronymDIORAMA
Study typeObservational study
Brief description of the studyDepression is a common mental illness, which concerns 4.8% of the French population and is associated with a high psychological, social and economic burden. In 15 to 30% of the depressive episodes, the depression becomes resistant to treatment but these estimates are not accurate since the notion of treatment-resistant depression (TDR) is difficult to define precisely. Conventionally, TRD involves depression that fails to improve adequately after the use of 2 AD (whether or not they are from different pharmacological class) at doses and durations that would normally be effective, administered to a patient believed to be adherent (3). Patients suffering from TRD experience a disproportionate burden of illness with significant impairment, increased morbidity, and higher economic costs than those of a treatment responsive depression case (4). The global epidemiological situation and the clinical characteristics of TDR are thus poorly understood and require further study, especially in France. With the development of a new medication for the treatment of TRD, Janssen-France requests that the Bordeaux PharmacoEpi (BPE) platform, CIC Bordeaux CIC1401 of Bordeaux University, carries out a study in France to estimate the frequency of, the risk factors and the costs for TRD using the SNIIRAM nation-wide claims and hospital database.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.bordeauxpharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed12/12/2016
Start date of data collection30/06/2017
Start date of data analysis30/09/201730/09/2017
Date of interim report, if expected
Date of final study report31/01/201931/01/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJANSSEN-FRANCE100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1Bâtiment Le Tondu, case 41, 146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux Cedex 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579563 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1Bâtiment Le Tondu, case 41, 146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux Cedex 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579563 
Alternative phone number 
Fax number (incl. country code)33557574740 
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