Rationale: Over 1 million Dutch persons currently use antidepressants (ADs), with depression being the main indication. Research shows that maintenance treatment after depression remission can decrease relapse. However, long-term AD use also results in disturbing side effects, medicalization, reduced autonomy and strongly contrasts with patients’ preferences. Current treatment guidelines state that AD use should be continued until at least 4 months of stable depression remission. However, after this period, there is much uncertainty whether, when and in whom discontinuation of ADs is effective.
Objective: This project will address this uncertainty by answering the question: What are, after reaching 4-month stable remission, the effects of early (immediate) AD discontinuation versus later (after 6 more AD treatment months) AD discontinuation?.
Study design: A cohort of ~2000 depressed patients who recently started AD treatment are monitored for the occurrence of 4-month stable depression remission. 400 patients with such remission are included in a randomized double-blind placebo-controlled trial (RCT) in which patients are randomized (1:1) to early discontinuation (1 month tapering, 11 months placebo) versus later discontinuation (6 months AD, 1 month tapering, 5 months placebo). The RCT is complemented with a non-randomized ‘external reference’ group of 200 patients to evaluate generalizability and usual care comparability of trial outcomes.
Outcomes: Primary outcome is sustained remission time (time without severe depressive symptoms, hospitalization for depression or suicide ideation or attempt). Secondary outcomes are functioning, quality of life, severity of mood, anxiety and somatic (e.g. side-effects) symptoms and cost effectiveness. Outcomes are (partly online) determined at baseline and after 1½, 3, 4½, 6, 7½, 9, 10½, 12, 18, 24 months. Cost effectiveness is evaluated from a societal perspective and determinants of discontinuation success are examined.