Major Depressive Disorder (MDD) is a psychiatric disorder commonly referred to as depression. Patients diagnosed with MDD consistently experience at least five symptoms from a list. When the first two types of antidepressant treatment given to a patient with MDD are not adequately effective, the patient is considered to have Treatment-Resistant Depression (TRD).
Many forms of therapy exist for MDD including drugs (e.g. anti-depressants, anti-psychotics, anticonvulsants), procedures (e.g. Electroconvulsive Therapy (ECT)) and therapies which do not involve drugs (e.g. psychotherapy, occupational therapy). However, the range of therapies currently available remain unsatisfactory for a large number of patients. Therefore, a need exists for new treatments with improved effectiveness.
The objective of this study is to describe characteristics of the MDD and TRD patient populations of the UK, to explore the treatments currently taken by patients in the UK, and to describe the cost of managing and treating patients in the UK. This will help to explore how a new and more effective treatment might be beneficial in the UK.
To achieve these objectives, data from patients who were diagnosed with MDD between January 2011 and May 2015 will be used from diagnosis to the point at which data is no longer available (2017).
This study aims to better understand the epidemiology and pharmacoeconomics of MDD and TRD, and the current treatment pathways used in the treatment of these conditions in the UK, which will in turn allow Janssen to ascertain whether there is a specific unmet need within these patient groups regarding the treatment options currently available, and thus highlighting the need for new treatments. The results of this study will also be used to inform a submission to a UK Health Technology Assessment (HTA) body to determine the relevance of currently-available comparators.
Methods:
To address the study objectives, a retrospective, longitudinal cohort design will be employed in incident MDD patients identified between January 2011 and May 2015 using linked CPRD-HES-MHDS data. Patients will be indexed on the date of first AD prescription within the indexing period and all indexed patients will be followed up for a minimum of 180 days, with the exception of those who die in the 180 days following indexing. Linked CPRD-HES data will be used to address all objectives. Linked CPRD-HES data will be used in conjunction with MHDS data to describe the use of non-pharmacological treatments.
Data analysis:
All analyses will be predominantly descriptive in nature, with all outcomes reported using appropriate descriptive statistics. Statistical testing will be utilised between subgroups, where applicable, in addition to Kaplan-Meier estimates (for time-to-event analyses) and generalised linear models (for regression modelling). Analyses pertaining to the primary and secondary objectives will include estimation of incidence of MDD and TRD, description of treatment pathways and treatment outcomes at each line of therapy and description of baseline demographics and clinical characteristics. Unit costs will be derived from secondary care data using Healthcare Resource Groups (HRGs), and from primary care through imputation from appropriate sources.
Incidence of MDD; Incidence of TRD; Treatment patterns (treatments prescribed, dose prescribed, treatment dynamics and number of lines of therapy received); Baseline demographics (age, sex, region, ethnicity); Clinical characteristics (number of episodes, episode type, TRD diagnosis and comorbidities); Treatment outcomes (relapse, recovery, recurrence, remission and response); Hospitalisations (length of stay, intensive care required).
Tom Denee - Chief Investigator - Janssen Pharmaceuticals UK
Robert Wood - Corresponding Applicant - Adelphi Real World
- Collaborator -
Chloe Middleton - Collaborator - Adelphi Real World
Cicely Kerr - Collaborator - Janssen Pharmaceuticals UK
Gemma Scott - Collaborator - Janssen Pharmaceuticals UK
John Waller - Collaborator - Adelphi Real World
Laleh Safinia - Collaborator - Janssen Pharmaceuticals UK
Mitesh Desai - Collaborator - Janssen Pharmaceuticals UK
Olivia Massey - Collaborator - Adelphi Real World
Rishender Singh - Collaborator - Janssen Pharmaceuticals UK
Theo Tritton - Collaborator - Adelphi Real World
HES Admitted Patient Care;HES Outpatient;Mental Health Services Data Set (MHSDS)