{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T12:53:08Z","timestamp":1792414388657,"version":"4.4.0"},"reference-count":54,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T00:00:00Z","timestamp":1737331200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Options for \u2018treatment-resistant bipolar depression\u2019 (TRBD) are limited. Two small, short-term, trials of pramipexole suggest it might be an option.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>To evaluate the clinical effectiveness and safety of pramipexole in the management of TRBD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A multi-centre randomised, double-blind controlled trial including participants \u2a7e18\u2009years old with TRBD (failure to respond, tolerate or clinical contraindication\/patient refusal of \u2a7e2 of quetiapine, olanzapine, lamotrigine or lurasidone) randomised 1:1 to pramipexole (max 2.5\u2009mg\/day salt weight) or placebo added to ongoing mood stabiliser ( n\u2009=\u200939). Primary outcome: Quick Inventory of Depressive Symptoms, Self-rated (QIDS-SR) at 12 weeks. Up to 48\u2009weeks follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Pramipexole ( n\u2009=\u200918) was associated with a greater reduction in QIDS-SR score at 12\u2009weeks versus placebo ( n\u2009=\u200921, 4.4 (4.8) vs 2.1 (5.1)): a medium sized ( d\u2009=\u2009\u22120.72) but not statistically significant difference (95% CI: \u22120.4 to 6.3, p\u2009=\u20090.087). Similarly, there was a non-significant approximate 2-point ( d\u2009=\u2009\u22120.76) improvement in pleasure at 6\u2009weeks (95% CI: \u22120.11 to 4.20). Significant advantages of pramipexole on QIDS-SR score (6.28\u2009points: 95% CI: 1.85\u201310.71) and psychosocial function (5.36\u2009points: 95% CI: 0.38\u201310.35) were seen at 36\u2009weeks post-randomisation, and on the response (46% vs 6%; p\u2009=\u20090.026) and remission (31% vs 0%; p\u2009=\u20090.030) rates at trial exit (48\u2009weeks or last available data after 16\u2009weeks for those affected by the early study closure). Hypomania ratings were significantly higher at 12\u2009weeks. Otherwise, pramipexole was well tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Clinically large, but statistically non-significant, effects of pramipexole on depression at 12\u2009weeks, 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/02698811241309622","type":"journal-article","created":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T04:33:46Z","timestamp":1737347626000},"page":"106-120","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["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)"],"prefix":"10.1177","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9966-1834","authenticated-orcid":false,"given":"R Hamish","family":"McAllister-Williams","sequence":"first","affiliation":[{"name":"Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK"},{"name":"Northern Centre for Mood Disorders, Newcastle University, Newcastle upon Tyne, 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