Depression Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 75 years old and over 2. Either 2 or more previous episodes of depression treated with antidepressants (any antidepressant for any length of time) OR taking any antidepressant for at least 2 years at any time 3. Currently has been taking either citalopram, sertraline or mirtazapine for at least 9 months, of which the last 3 months should be at the following doses: 20mg citalopram, 50 mg sertraline or 30mg mirtazapine. These 9 months can be included in the 2 years stated in inclusion 2 4. Currently not depressed (scores <5 on 15-item Geriatric Depression Scale) and are now well enough to consider stopping the antidepressant 5. Presence of a Study Partner (a family member, friend or formal caregiver) who sees or speaks to the participant at least once a week and is prepared to support the completion of outcome measures that involve recall of the previous 8 weeks 6. Provides Informed Consent
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Bipolar Disorder 2. Diagnosis of Dementia (although people with mild cognitive impairment will be eligible for the trial) 3. Currently prescribed a combination of antidepressants or an antidepressant and a mood stabiliser or an antipsychotic as this would indicate individuals with a history of more severe depression who would be at higher risk of relapse of depression 4. Participation in another interventional study 5. Participated in a CTIMP or a trial of psychological intervention in the preceding 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to first relapse of depression during the 52-week follow-up, as determined in a time-to-event analysis. This will be determined using the Clinician Interview Schedule-Revised (rCIS-R) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression measured using the Geriatric Depression Scale (GDS-15) at baseline and weeks 8, 16, 24, 32, 40, 48 and 52 2. Symptoms of anxiety measured using the Generalised Anxiety Disorder Assessment 7-item version (GAD7) at baseline and weeks 8, 16, 24, 32, 40, 48 and 52 3. Physical symptoms of side effects of antidepressants measured using the Toronto Side Effect Scale at baseline and weeks 8, 16, 32 and 48 weeks 4. Antidepressant withdrawal effects measured using a modified 17-item version of the Discontinuation-Emergent Signs and Symptoms (DESS) checklist at baseline and weeks 4, 8, 12, 14, 16 and 18 5. Quality of Life Scores for Physical and Mental Health measured using the 12-item Short-Form Survey (SF-12) at baseline and weeks 24 and 52 6. Cognitive Functioning measured using the Montreal Cognitive Assessment (MOCA) at baseline and weeks 24 and 52 7. Adherence to study medication measured using a single question at each follow-up 8. Levels of Fitness-Frailty, polypharmacy and multimorbidity measured using the Pictorial Fit-Frail Scale (PFFS) at baseline and weeks 24 and 52 9. Resource for health and social care measured using a modified version of the Client Service Receipt Inventory (CSRI) at baseline and weeks 24 and 52 10. Health Quality of life measured using the EQ-5D-5L (a five-item, five-level questionnaire) at baseline and weeks 24 and 52 11. Understanding older adults' decision-making about antidepressants and their experience of reducing and stopping measured using qualitative follow-up interviews after collection of primary endpoint data 12. Understanding the perspective of GPs on the diagnosis and management of depression in older adults measured using qualitative interviews after collection of primary endpoint data | — |
Countries
England, United Kingdom