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

Phase 4

• Conditions: Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN26190474
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-22
• Last Update Posted: 2 September 2024
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 430

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)