Resistant Depression in France, description from the nationwide claims and hospitalization database (DIORAMA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49894
• EU PAS number:
  EUPAS20778
• Study ID:
  49894
• Official title and acronym:
  Resistant Depression in France, description from the nationwide claims and hospitalization database (DIORAMA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Depression 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 12/12/2016

Study start date

Actual: 30/06/2017

Data analysis start date

Planned: 30/09/2017

Actual: 30/09/2017

Date of final study report

Planned: 31/01/2019

Actual: 31/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

JANSSEN-FRANCE

Study protocol

Initial protocol

DIORAMA-v1.4-20170828

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable