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Discontinuation of antidepressant medication after mindfulness-based cognitive therapy for recurrent depression: randomised controlled non-inferiority trial.

Marloes J. Huijbers, Philip Spinhoven, Jan Spijker, Henricus G. Ruhé, Digna J F Van Schaik, Patricia Van Oppen, Willem A Nolen, Johan Ormel, Willem Kuyken, Gert Jan Van der Wilt, Marc B J Blom, Aart H Schene, A Rogier, T Donders, Anne E. M. Speckens

The British Journal of Psychiatry April 2016 DOI: 10.1192/bjp.bp.115.168971 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Multicentre randomised controlled non-inferiority trial Randomized Peer reviewed
Sample size 249
Population Adults with recurrent depression in remission who had been using maintenance antidepressant medication for 6 months or longer
Interventions Mindfulness-based cognitive therapy (MBCT) maintenance antidepressant medication (mADM)
Duration 15-month follow-up
Topics Depression Meditation
Registration NCT00928980
Key findings Discontinuing maintenance antidepressants after MBCT was not non-inferior to continuing them: the difference in relapse/recurrence rates within 15 months exceeded the 25% non-inferiority margin, and time to relapse/recurrence was significantly shorter after discontinuation. Depression severity showed only minor differences between groups. The authors suggest an increased risk of relapse/recurrence in patients withdrawing from maintenance antidepressants after MBCT.

Abstract

Mindfulness-based cognitive therapy (MBCT) and maintenance antidepressant medication (mADM) both reduce the risk of relapse in recurrent depression, but their combination has not been studied. To investigate whether MBCT with discontinuation of mADM is non-inferior to MBCT+mADM. A multicentre randomised controlled non-inferiority trial (ClinicalTrials.gov:NCT00928980). Adults with recurrent depression in remission, using mADM for 6 months or longer (n= 249), were randomly allocated to either discontinue (n= 128) or continue (n= 121) mADM after MBCT. The primary outcome was depressive relapse/recurrence within 15 months. A confidence interval approach with a margin of 25% was used to test non-inferiority. Key secondary outcomes were time to relapse/recurrence and depression severity. The difference in relapse/recurrence rates exceeded the non-inferiority margin and time to relapse/recurrence was significantly shorter after discontinuation of mADM. There were only minor differences in depression severity. Our findings suggest an increased risk of relapse/recurrence in patients withdrawing from mADM after MBCT.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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