Browse by author
Lookup NU author(s): Dr Stuart Watson
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. 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): Au-Yeung SK, Griffiths J, Roberts S, Edwards C, Yu L-M, Bogacz R, Rendell J, Attenburrow M-J, Watson S, Chan F, Cipriani A, Cleare A, Harmer CJ, Kessler D, Evans J, Lewis G, Singh I, Simon J, Harrison PJ, Cowen P, Shanyinde M, Geddes J, Browning M
Publication type: Article
Publication status: Published
Journal: Evidence-Based Mental Health
Year: 2022
Volume: 25
Issue: 2
Pages: 77-83
Print publication date: 01/05/2022
Online publication date: 22/11/2021
Acceptance date: 02/04/2018
Date deposited: 09/05/2022
ISSN (print): 1362-0347
ISSN (electronic): 1468-960X
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/ebmental-2021-300282
DOI: 10.1136/ebmental-2021-300282
PubMed id: 34810175
Altmetrics provided by Altmetric
