Pramipexole augmentation for treatment-resistant or anhedonic depression. The real-world evidence

Objective. The aim of the present study is to assess the real-world evidence on the effectiveness and safety of pramipexole augmentation of traditional antidepressants (ADs) in patients with unipolar and bipolar treatment resistant depression (TRD) or with anhedonic depression.

Methods. This systematic review included observational studies and case series on adults receiving pramipexole as an AD augmentation strategy for unipolar and bipolar TRD or for anhedonic depression.

Results. We identified 12 studies: eight tested the effectiveness and safety of pramipexole augmentation for TRD; one compared the effectiveness and safety of pramipexole and aripiprazole augmentation in patients with unipolar TRD; one evaluated the effectiveness and safety of pramipexole augmentation in patients with unipolar TRD who failed to respond to aripiprazole augmentation; and two evaluated the efficacy and tolerability of pramipexole in patients with anhedonic depression. Overall, there were 308 participants, 20%-69.5% were women, the mean age was 25-62.2 years, In patients with TRD, pramipexole augmentation showed to be effective (response rate ranged from 33% to 80%), to be significantly superior to aripiprazole augmentation (response rate 63.9% vs. 33.2%; p= 0.005), and to be comparably effective in patients previous failed the aripiprazole augmentation and previously not treated with aripiprazole augmentation (response rate 65.2% and 62.1%; p= 0.79). In patients with anhedonic depression significantly improved anhedonia and depressive symptoms.

Conclusion. The results of this systematic review show that off-label use of pramipexole as ADs augmentation could be a useful and safe strategy for unipolar and bipolar TRD and for anhedonic depression.