Major Depressive Disorder (MDD) is a psychiatric disorder commonly referred to as depression. Patients diagnosed with MDD consistently experience at least five symptoms or, which are experienced nearly every day in a 2-week period. Symptoms may include, depressed mood, loss of enjoyment in daily activities, significant change in weight, changes in sleep, changes in activity, loss of energy, feelings of guilt/worthlessness, difficulties with concentration, and suicidality. There are many different treatments for MDD including drug (anti-depressant) treatments, talking therapies etc. 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 Scotland, and to explore the treatments currently taken by patients in Scotland. This will help to explore how a new and more effective treatment might be beneficial in Scotland.
To achieve these objectives, data from patients who were diagnosed with MDD between January 2011 and May 2018 will be used from diagnosis to the point at which data is no longer available (2018).
Objectives:
This study aims to better understand the epidemiology of MDD and TRD and the current treatment pathways used in the treatment of these conditions in Scotland 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 2018 using CPRD 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.
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.
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);
Timothy Ming - Chief Investigator - Janssen Pharmaceuticals UK
Timothy Ming - Corresponding Applicant - Janssen Pharmaceuticals UK
Gemma Scott - Collaborator - Janssen Pharmaceuticals UK
Joachim Morrens - Collaborator - Janssen-Cilag Ltd
Joris Diels - Collaborator - Janssen Pharmaceutica NV
Timothy Ming - Collaborator - Janssen Pharmaceuticals UK
Tom Denee - Collaborator - Janssen Pharmaceuticals UK