Treatment Outcomes for Patients with Treatment Resistant Depression in European Standard Clinical Practice

Author(s)

Heerlein K1, Morrens J2, Degraeve G3, Hagedoorn W4, Sierra P5, Oliveira-Maia A6, Gali Y7, Malynn S8, Kambarov Y9, Rive B10, VanDooren G7, Verrijcken C7, Perugi G11
1Janssen EMEA, Neuss, Germany, 2Janssen EMEA, Beerse, VBR, Belgium, 3AZ Alma General Hospital, Eeklo and PC Dr Guislain Hospital, Ghent, Belgium, 4Practice for Psychiatry and Psychotherapy, Heerde, Netherlands, 5University and Polytechnic Hospital La Fe, University of Valencia, Valencia, Spain, 6Champalimaud Research and Clinical Centre, Champalimaud Centre for the Unknown, and NOVA Medical School Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal, 7Janssen EMEA, Beerse, Belgium, 8Janssen EMEA, Dublin, Ireland, 9Janssen EMEA, Almaty, Kazakhstan, 10Janssen EMEA, Paris, France, 11Clinica Universitaria, Pisa, Italy

OBJECTIVES

Treatment resistant depression (TRD), defined by failure to respond to ≥2 different antidepressants at adequate dose for adequate duration in the same major depressive episode (MDE), is associated with significant morbidity and mortality.1 Despite clear unmet need, few studies report treatment patterns and outcomes for TRD patients in standard clinical practice.2 This study aimed to examine disease burden and treatment outcomes with current standard of care among TRD patients in Europe.

METHODS

A prospective, multicentre, observational cohort study was conducted in adults with current TRD and Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20, initiating a new treatment for depression. Patient characteristics, medical history and treatment outcomes were collected from medical records, clinician-rated interviews and patient-reported questionnaires.

RESULTS

The final analysis set included 411 patients. At baseline, patients scored highly for depression (mean MADRS score: 31.8) and functional impairment (mean Work Productivity and Activity Impairment of overall activity: 73.3%; mean Sheehan Disability Scale total score: 22.4, with 74.2% markedly/extremely functionally impaired). At baseline, 41.4% of new treatments combined ≥2 antidepressants and 40.4% involved ≥1 augmentation drug. By Month 6, 8.6% of patients had been hospitalised (mean: 18.4 total inpatient days/hospitalised patient); 75.2% of patients had ≥1 consultation with a psychiatrist/neurologist, (mean: 4.7 consultations/patient). At Month 6, 16.7% (51/306) of patients were in remission (MADRS score ≤10) and 9.8% (30/306) exhibited response without remission (MADRS score >10, improvement from baseline ≥50%). Among Month 6 responders, 51.7% had relapsed by Month 12.

CONCLUSIONS

At Month 6, >70% of patients showed no response to standard of care and had high medical resource utilisation. More than half of Month 6 responders relapsed by Month 12. This highlights that, despite complex treatment regimens (i.e. augmentation and combination therapies), there are clear unmet needs in the treatment of TRD.

REFERENCES

  1. EMA 2013. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-depression_en.pdf [Accessed:06/02/2020]; 2. Jaffe D. BMC Psychiatry 2019;19:247.

Conference/Value in Health Info

2020-11, ISPOR Europe 2020, Milan, Italy

Value in Health, Volume 23, Issue S2 (December 2020)

Code

PMH2

Topic

Clinical Outcomes, Economic Evaluation, Patient-Centered Research

Topic Subcategory

Clinician Reported Outcomes, Patient-reported Outcomes & Quality of Life Outcomes

Disease

Mental Health

Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×