A randomised double-blind, placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment-resistant bipolar depression (the PAX-BD study).

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Tác giả: Lumbini Azim, Victoria Bartle, Michael Berger, Chrissie Butcher, Thomas Chadwick, Emily Clare, Paul Courtney, Lyndsey Dixon, Nichola Duffelen, Tony Fouweather, William Gann, John Geddes, Nicola Goudie, Sumeet Gupta, Beth Hall, Timea Helter, Paul Hindmarch, Eva-Maria Holstein, Ward Lawrence, Phil Mawson, R Hamish McAllister-Williams, Iain McKinnon, Adam Milne, Aisling Molloy, Abigail Moore, Richard Morriss, Anisha Nakulan, Judit Simon, Daniel Smith, Paul Ra Stokes, Bryony Stokes-Crossley, Andrew Swain, Adeola Taiwo, Zoë Walmsley, Stuart Watson, Christopher Weetman, Allan H Young

Ngôn ngữ: eng

Ký hiệu phân loại: 362.19 Services to patients with specific conditions

Thông tin xuất bản: United States : Journal of psychopharmacology (Oxford, England) , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 160512

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 2.5 mg/day salt weight) or placebo added to ongoing mood stabiliser ( RESULTS: Pramipexole ( 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. Furthermore, larger randomised placebo-controlled trials are warranted.
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