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Antidepressants to prevent relapse in depression in older people aged 75 years and over

Antidepressants to prevent relapse in depression in older people (ANTLER 75+ Trial) – a double blind randomised controlled trial to evaluate the effectiveness and cost-effectiveness of continuing antidepressants

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26190474
Enrollment
430
Registered
2024-08-22
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mental and Behavioural Disorders

Interventions

The Intervention will be a continuation of the antidepressant medication that the participants are already taking compared to tapering and discontinuing the antidepressant medication to estimate the e

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactSue Philpott
s.philpott@ucl.ac.uk+44 (0)20 7670 4813

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026