A study to understand the impact of depression

  • Research type

    Research Study

  • Full title

    A research study to understand the impact of depression on the lives of people with depression and on the family and friends who support them

  • IRAS ID

    261688

  • Contact name

    Shanaya Rathod

  • Contact email

    shanaya.rathod@southernhealth.nhs.uk

  • Sponsor organisation

    Janssen-Cilag Limitd

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    0 years, 9 months, 16 days

  • Research summary

    This is a UK mixed-methods, non-interventional research study of the impact of depression on patients and carers. This study will be conducted in approx. 6 NHS sites in the United Kingdom (UK) including primary and secondary care sites. The population for this study is adult patients diagnosed with Major Depressive Disorder (MDD), Treatment-resistant Depression (TRD) and Treatment-resistant Depression (TRD)in remission who have received treatment with oral antidepressant medication, and carers of patients with TRD/TRD in remission. MDD is defined as a mood disorder characterised by persistent low mood and/or a loss of interest and energy in activities for at least 2 weeks. TRD is defined as depression that has been treated with at least two different oral antidepressant agents and showed lack of improvement within a single major depressive episode. TRD in remission is defined as free of depressive symptoms for at least four weeks after an episode of depression that met the criteria for TRD.

    The study has 3 components: completion of patient and carer questionnaire at a single point in time, interviews with patients and carers who completed the questionnaires and retrospective data collection from patients' medical records.

    There will be no changes to patient management for the purposes of the study.

    It is expected to recruit approx. 400 participants in total.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    19/NW/0146

  • Date of REC Opinion

    5 Apr 2019

  • REC opinion

    Further Information Favourable Opinion