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10.1136-ebmental-2021-300282 |
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|a 1468960X (ISSN)
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|a PAX-D: study protocol for a randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression
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|b NLM (Medline)
|c 2022
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|z View Fulltext in Publisher
|u https://doi.org/10.1136/ebmental-2021-300282
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|a INTRODUCTION: Clinical depression is usually treated in primary care with psychological therapies and antidepressant medication. However, when patients do not respond to at least two or more antidepressants within a depressive episode, they are considered to have treatment resistant depression (TRD). Previous small randomised controlled trials suggested that pramipexole, a dopamine D2/3 receptor agonist, may be effective for treating patients with unipolar and bipolar depression as it is known to influence motivational drive and reward processing. PAX-D will compare the effects of pramipexole vs placebo when added to current antidepressant medication for people with TRD. Additionally, PAX-D will investigate the mechanistic effect of pramipexole on reward sensitivity using a probabilistic decision-making task. METHODS AND ANALYSIS: PAX-D will assess effectiveness in the short- term (during the first 12 weeks) and in the longer-term (48 weeks) in patients with TRD from the UK. The primary outcome will be change in self-reported depressive symptoms from baseline to week 12 post-randomisation measured using the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Performance on the decision-making task will be measured at week 0, week 2 and week 12. Secondary outcomes include anhedonia, anxiety and health economic measures including quality of life, capability, well-being and costs. PAX-D will also assess the adverse effects of pramipexole including impulse control difficulties. DISCUSSION: Pramipexole is a promising augmentation agent for TRD and may be a useful addition to existing treatment regimes. PAX-D will assess its effectiveness and test for a potential mechanism of action in patients with TRD. TRIAL REGISTRATION NUMBER: ISRCTN84666271. © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
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|a adult psychiatry
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|a depression & mood disorders
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|a psychiatry
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|a Attenburrow, M.-J.
|e author
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|a Au-Yeung, S.K.
|e author
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|a Bogacz, R.
|e author
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|a Browning, M.
|e author
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|a Chan, F.
|e author
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|a Cipriani, A.
|e author
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|a Cleare, A.
|e author
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|a Cowen, P.
|e author
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|a Edwards, C.
|e author
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|a Evans, J.
|e author
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|a Geddes, J.
|e author
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|a Griffiths, J.
|e author
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|a Harmer, C.J.
|e author
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|a Harrison, P.J.
|e author
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|a Kessler, D.
|e author
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|a Lewis, G.
|e author
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|a Rendell, J.
|e author
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|a Roberts, S.
|e author
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|a Shanyinde, M.
|e author
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|a Simon, J.
|e author
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|a Singh, I.
|e author
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|a Watson, S.
|e author
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|a Yu, L.-M.
|e author
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|t Evidence-based mental health
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