OBJECTIVE: Several depressed patients do not respond to traditional antidepressants. Our aim was to systematically review the effectiveness and safety of pramipexole in unipolar and bipolar depression.
METHODS: We conducted a systematic review of randomised clinical trials (RCTs) and observational studies on pramipexole for patients with major depressive episodes, following PRISMA guidelines. Our primary outcome measure was treatment response at endpoint. The study protocol was registered on PROSPERO: CRD42018108699.
RESULTS: We found five RCTs, three open label trials and five observational studies, with 504 participants (57% women; mean age, 45.3 years; mean sample size, 39; median duration of treatment, 8 weeks; mean follow-up duration, 45 weeks; mean maximum dose, 1.62 mg). We found an overall short-term response rate of 52.2% and remission rate of 36.1%, and an overall long-term response rate of 62.1% and remission rate of 39.6%. In RCTs, patients treated with pramipexole, had a superior response rate compared with placebo (RR: 1.77; 95%CI: 1.11 to 2.82) and similar to SSRIs (RR: 0.93; 95%CI: 0.44 to 1.95). Acceptability and tolerability were good, with nausea being the most frequent side effect.
CONCLUSION: Our study found some evidence for an effect of pramipexole for the treatment of major depressive episodes. This article is protected by copyright. All rights reserved.