The ZonMw Good Use Medicines program has stopped financing the OPERA study. The reason for this is the strongly lagging inclusion of participants.
The OPERA (Netherlands study of Optimal, PERsonalized Antidepressant use) is a randomized placebo-controlled study investigating the short- and long-term effects of early withdrawal of antidepressants versus later withdrawal. The study focuses on the group of patients who had recently started taking antidepressants. The OPERA study was started in January 2019 with the aim of providing clinicians and patients with clear guidelines for tapering off antidepressants.
The OPERA study consists of two parts: OPERA monitor, in which the occurrence of recovery of antidepressant users is mapped, and then OPERA taper, in which patients recovered from OPERA monitor, blinded, taper their antidepressants early or later.
OPERA phasing out stopped
Since the start of the study, too few participants could be included for the OPERA phasing out component via the OPERA monitor. This is partly because fewer people than expected achieved a stable recovery or because they did not meet the inclusion criteria. Since the necessary intake of participants could not be changed in the foreseeable future, it was decided to stop the project. All participants who were active in OPERA phasing out have now been informed, as have the treating physicians of the participants who were still using study medication at that time.
OPERA monitor continues
At the initiative of the OPERA consortium, under the direction of the Amsterdam UMC, OPERA monitor will be continued until a number of 950 participants. OPERA monitor is investigating recovery from depression in patients who have recently started taking antidepressants (citalopram or sertraline). In these patients it is investigated when and in whom the depression recovers well. It is also being investigated when and how people subsequently stop taking antidepressants. ZonMw sees the OPERA consortium’s choice to let the OPERA monitor run independently for longer as a great opportunity to get a better picture of recovery from depression and stopping antidepressants in this group of patients.
Participants can still register for OPERA-monitor until December 2022: opera-project.nl. Participants will be followed up to and including December 2023, by means of online questionnaires and telephone interviews.