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
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
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
6. Study drug(s) information
Substance class (ATC Code)N06A (ANTIDEPRESSANTS)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects1000000
Additional information
World Health Organization Depression has estimated the prevalence of depressive disorders in 2015 in France at 4.8%. In 15 to 30% of the depressive episodes, the depression becomes resistant to treatment. This corresponds to an effective varying from 480 000 to 1 million French individuals – between 4 800 to 10 000 persons in the EGB within a 1-year period.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
EGB, France
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To estimate the prevalence and incidence of Treatment-Resistant Depression in the French population.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
a maximum of 3 years of follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
A Statistical Analysis Plan (SAP) was developed and validated by the Scientific Committee before the analysis. The statistical analysis was performed using the SAS® software (latest current version), following a detailed statistical analysis plan.
The following analyses were performed:
• A flow chart depicting the number of patients and sequences of treatment available in the database satisfying the inclusion criteria;
• Description of baseline characteristics, comorbidities;
• Description of the TDR episode;
• Description of the TRD prevalence and incidence in 2012, 2013 and 2014, averaged per year and age- and sex-standardized to the French population;
• Description of healthcare resources use during the TRD episode and during the follow-up period.