Major depressive disorder (MDD) is a mental disorder characterized by a pervasive and persistent low mood that is accompanied by low self-esteem and by a loss of interest or pleasure in normally enjoyable activities. Major depression can be mild, moderate or severe. Symptoms can induce clinically significant impairment in social, work, or other important areas of functioning almost every day. This can lead to isolation of the person suffering from MDD and sufferers at the severe end of the spectrum may experience such low self-worth that they contemplate ending their life. In the worst case this may result in suicide. Patients at imminent risk of suicide require close attention and monitoring to protect them from attempting suicide and to help develop effective suicide prevention strategies. Given the social stigma surrounding suicide, such attempted incidents may not be systematically or routinely recorded in patient medical records. Furthermore, patients may be reluctant to fully disclose suicidal thoughts or active suicidal plan to their health care professionals so a retrospective analysis may provide some insight into prior indicators of subsequent events.
This study aims to analyse both primary and secondary care data in order to fill some of the evidence gaps on patients with MDD at imminent risk for suicide in the United Kingdom (UK). This study will provide an overview of the patient pathway and information on the incidence, patient characteristics, and healthcare resource use of MDD patients with imminent risk for suicide in the UK.
We will conduct a descriptive, retrospective, longitudinal cohort study to estimate the incidence and characterise major depressive disorder (MDD) patients who are at imminent risk for suicide in England.
Clinical Practice Research Datalink (CPRD) data linked to Hospital Episode Statistics (HES) data, Mental Health Data Set (MHDS) data, and Office for National Statistics (ONS) data will be used. The overall study duration will be 140 months, from April 2007 to December 2018. The period from April 2007 to November 2015 corresponds to the linkage coverage period of MHDS. The study period will be expanded until December 2018 to have a longer follow-up to assess some of the outcomes. The index date will be defined as the date of the first recorded suicide intention. For patients with an initial suicide intention prior to their MDD diagnosis, subjects will be considered as MDD patients if they have a diagnosis of MDD within three months of this episode of suicide intention. This delay will allow patients whose MDD is first diagnosed following a suicide attempt or an episode of suicide intention to be recorded as MDD patients in the database, as for hospitalised patients diagnosis recording is often not done imminently. Descriptive statistics on demographic/clinical patients characteristics, healthcare resource use, admissions in mental health teams and pharmacological/interventional and non-pharmacological treatment patterns will be generated at index date, at MDD diagnosis and during follow-up. Continuous variables will be described based on mean, median, standard deviation, minimum and maximum values and number of non-missing cases. For categorical variables, we will provide the number and percentage of patients for each modality and the proportion of missing data. Statistical tests will also be conducted to compare characteristics of MDD with and without imminent risk of suicide (Chi-square tests and Students t-tests for respectively qualitative and quantitative characteristics). Predictive factors associated with mortality in MDD patients at imminent risk for suicide will be investigated using logistic regression models adjusted on characteristics at index date.
Incidence, demographic and clinical characteristics, comorbidities and time to discharge for hospitalised MDD patients with imminent risk of suicide; a comparison of demographic and clinical characteristics with MDD patients without imminent risk of suicide; healthcare resource use; suicidality risk levels; mortality; level of depressive symptoms (using PHQ-9).
Depending on the data availability: treatment pathway and predictive factors for mortality in MDD with imminent risk of suicide.
Tom Denee - Chief Investigator - Janssen Pharmaceuticals UK
Juliette Murris - Corresponding Applicant - Amaris
Aline Gauthier - Collaborator - Amaris
Astrid Foix Colonier - Collaborator - Amaris France
Cicely Kerr - Collaborator - Janssen Pharmaceuticals UK
Claire Fischer - Collaborator - Amaris
Gemma Scott - Collaborator - Janssen Pharmaceuticals UK
Léa Letty - Collaborator - Amaris France
Sarah Richards - Collaborator - Janssen Pharmaceuticals UK
Sophie Marguet - Corresponding Applicant - Amaris
Christine Brett - Collaborator - Amaris
Claudia Carlucci - Collaborator - Amaris
Juliette Murris - Collaborator - Amaris
Mitesh Desai - Collaborator - Janssen Pharmaceuticals UK
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Mental Health Services Data Set (MHSDS);ONS Death Registration Data