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
| Autor: | Catherine J. Harmer, Ilina Singh, Ly-Mee Yu, Judit Simon, Paul Harrison, Glyn Lewis, Chloe Edwards, Sophie Roberts, Phil J. Cowen, Jennifer M Rendell, Sheena K. Au-Yeung, James Griffiths, Fiona Chan, Stuart Watson, Rafal Bogacz, Michael Browning, Anthony J. Cleare, Jonathan Evans, Milensu Shanyinde, John R. Geddes, David Kessler, Andrea Cipriani, M J Attenburrow |
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| Rok vydání: | 2021 |
| Předmět: |
Depressive Disorder
Major medicine.medical_specialty Pramipexole Depression business.industry Placebo-controlled study Anhedonia Placebo medicine.disease Antidepressive Agents Depressive Disorder Treatment-Resistant Psychiatry and Mental health Quality of life Quality of Life medicine Physical therapy Humans Anxiety medicine.symptom business Adverse effect Treatment-resistant depression Randomized Controlled Trials as Topic medicine.drug |
| Zdroj: | Au-Yeung, S K, 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, C J, Kessler, D, Evans, J, Lewis, G, Singh, I, Simon, J, Harrison, P J, Cowen, P, Shanyinde, M, Geddes, J & Browning, M 2021, ' 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 ', Evidence-Based Mental Health . https://doi.org/10.1136/ebmental-2021-300282 |
| ISSN: | 1468-960X 1362-0347 |
| DOI: | 10.1136/ebmental-2021-300282 |
| Popis: | IntroductionClinical 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 analysisPAX-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.DiscussionPramipexole 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 numberISRCTN84666271 |
| Databáze: | OpenAIRE |
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