Browse by author
Lookup NU author(s): Professor Hamish McAllister-WilliamsORCiD, Nicola GoudieORCiD, Lumbini Azim, Victoria Bartle, Chrissie Butcher, Dr Thomas Chadwick, Emily Clare, Tony Fouweather, Beth Hall, Paul Hindmarch, Dr Eva-Maria Holstein, Phil Mawson, Dr Iain McKinnonORCiD, Adam Milne, Abigail Moore, Dr Anisha Nakulan, Andrew Swain, Zoe WalmsleyORCiD, Christopher Weetman, Dr Stuart Watson
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Background Options for “treatment resistant bipolar depression” (TRBD) are limited. Two small, short-term, trials of pramipexole suggest it might be an option. Aims To evaluate the clinical effectiveness, and safety, of pramipexole in the management of TRBD. Methods A multi-centre randomised, double-blind controlled trial including participants ≥18 years old with TRBD (failure to respond, tolerate, or clinical contraindication/patient refusal of ≥2 of quetiapine, olanzapine, lamotrigine or lurasidone) randomised 1:1 to pramipexole (max 2.5mg/day salt weight) or placebo added to ongoing mood stabiliser (n=39). Primary outcome: Quick Inventory of Depressive Symptoms, Self-rated (QIDS-SR) at 12 weeks. Up to 48 weeks follow-up. Results Pramipexole (n=18) was associated with a greater reduction in QIDS-SR score at 12 weeks versus placebo (n=21, 4.4(4.8) vs 2.1(5.1)): a medium sized (d=-0.72) but not statistically significant difference (95%CI: -0.4-6.3, p=0.087). Similarly, there was a non-significant approximate 2-point (d=-0.76) improvement in pleasure at 6 weeks (95%CI: -0.11-4.20). Significant advantages of pramipexole on QIDS-SR score (6.28 points: 95%CI 1.85-10.71) and psychosocial function (5.36 points: 95%CI: 0.38-10.35) were seen at 36 weeks post-randomisation, and on response (46% vs 6%; p=0.026) and remission (31% vs 0%; p=0.030) rates at trial exit (48 weeks or last available data after 16 weeks for those affected by the early study closure). Hypomania ratings were significantly higher at 12 weeks. Otherwise, pramipexole was well tolerated. Conclusions Clinically large, but statistically non-significant, effects of pramipexole on depression at 12 weeks, with significant longer-term benefits on mood and function were observed. Pramipexole use was complicated by dose titration and increased hypomanic symptoms. The small sample size limits interpretation. Further larger RCTs are warranted.
Author(s): McAllister-Williams RH, Goudie N, Azim L, Bartle V, Berger M, Butcher C, Chadwick T, Clare E, Courtney P, Dixon L, Duffelen N, Fouweather T, Gann W, Geddes J, Gupta S, Hall B, Helter T, Hindmarch P, Holstein EM, Lawrence W, Mawson P, McKinnon I, Milne A, Molloy A, Moore A, Morriss R, Nakulan A, Simon J, Smith D, Stokes-Crossley B, Stokes P, Swain A, Taiwo A, Walmsley Z, Weetman C, Young A, Watson S
Publication type: Article
Publication status: Published
Journal: Journal of Psychopharmacology
Year: 2025
Pages: epub ahead of print
Online publication date: 20/01/2025
Acceptance date: 04/12/2024
Date deposited: 20/01/2025
ISSN (print): 0269-8811
ISSN (electronic): 1461-7285
Publisher: Sage Publications Ltd.
URL: https://doi.org/10.1177/02698811241309622
DOI: 10.1177/02698811241309622
Altmetrics provided by Altmetric
