Discontinuation of antidepressant medication after mindfulness-based cognitive therapy for recurrent depression: randomised controlled non-inferiority trial.
Huijbers MJ., Spinhoven P., Spijker J., Ruhé HG., van Schaik DJ., van Oppen P., Nolen WA., Ormel J., Kuyken W., van der Wilt GJ., Blom MB., Schene AH., Rogier A., Donders T., Speckens AE.
BACKGROUND: 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. AIMS: To investigate whether MBCT with discontinuation of mADM is non-inferior to MBCT+mADM. METHOD: 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. RESULTS: 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. CONCLUSIONS: Our findings suggest an increased risk of relapse/recurrence in patients withdrawing from mADM after MBCT.