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Add-on pramipexole ...
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Lindahl, JesperLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups,Skåne University Hospital
(author)
Add-on pramipexole for anhedonic depression : study protocol for a randomised controlled trial and open-label follow-up in Lund, Sweden
- Article/chapterEnglish2023
Publisher, publication year, extent ...
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BMJ Publishing Group,2023
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9
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electronicrdacarrier
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LIBRIS-ID:oai:researchportal.hkr.se/admin:publications/7ed5d143-f92d-4eb5-a554-15df7809e611
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oai:researchportal.hkr.se/admin:publications/7ed5d143-f92d-4eb5-a554-15df7809e611URI
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https://doi.org/10.1136/bmjopen-2023-076900DOI
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https://lup.lub.lu.se/record/93bc3bfa-d802-4d80-ae47-5cd0457b2cf3URI
Supplementary language notes
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Language:English
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Summary in:Swedish &English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
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INTRODUCTION: Many depressed patients do not achieve remission with available treatments. Anhedonia is a common residual symptom associated with treatment resistance as well as low function and quality of life. There are currently no specific and effective treatments for anhedonia. Some trials have shown that dopamine agonist pramipexole is efficacious for treating depression, but more data is needed before it could become ready for clinical prime time. Given its mechanism of action, pramipexole might be a useful treatment for a depression subtype characterised by significant anhedonia and lack of motivation-symptoms associated with dopaminergic hypofunction. We recently showed, in an open-label pilot study, that add-on pramipexole is a feasible treatment for depression with significant anhedonia, and that pramipexole increases reward-related activity in the ventral striatum. We will now confirm or refute these preliminary results in a randomised controlled trial (RCT) and an open-label follow-up study. METHODS AND ANALYSIS: Eighty patients with major depression (bipolar or unipolar) or dysthymia and significant anhedonia according to the Snaith Hamilton Pleasure Scale (SHAPS) are randomised to either add-on pramipexole or placebo for 9 weeks. Change in anhedonia symptoms per the SHAPS is the primary outcome, and secondary outcomes include change in core depressive symptoms, apathy, sleep problems, life quality, anxiety and side effects. Accelerometers are used to assess treatment-associated changes in physical activity and sleep patterns. Blood and brain biomarkers are investigated as treatment predictors and to establish target engagement. After the RCT phase, patients continue with open-label treatment in a 6-month follow-up study aiming to assess long-term efficacy and tolerability of pramipexole. ETHICS AND DISSEMINATION: The study has been approved by the Swedish Ethical Review Authority and the Swedish Medical Products Agency. The study is externally monitored according to Good Clinical Practice guidelines. Results will be disseminated via conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05355337 and NCT05825235.
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Introduction Many depressed patients do not achieve remission with available treatments. Anhedonia is a common residual symptom associated with treatment resistance as well as low function and quality of life. There are currently no specific and effective treatments for anhedonia. Some trials have shown that dopamine agonist pramipexole is efficacious for treating depression, but more data is needed before it could become ready for clinical prime time. Given its mechanism of action, pramipexole might be a useful treatment for a depression subtype characterised by significant anhedonia and lack of motivation—symptoms associated with dopaminergic hypofunction. We recently showed, in an open-label pilot study, that add-on pramipexole is a feasible treatment for depression with significant anhedonia, and that pramipexole increases reward-related activity in the ventral striatum. We will now confirm or refute these preliminary results in a randomised controlled trial (RCT) and an open-label follow-up study. Methods and analysis Eighty patients with major depression (bipolar or unipolar) or dysthymia and significant anhedonia according to the Snaith Hamilton Pleasure Scale (SHAPS) are randomised to either add-on pramipexole or placebo for 9 weeks. Change in anhedonia symptoms per the SHAPS is the primary outcome, and secondary outcomes include change in core depressive symptoms, apathy, sleep problems, life quality, anxiety and side effects. Accelerometers are used to assess treatment-associated changes in physical activity and sleep patterns. Blood and brain biomarkers are investigated as treatment predictors and to establish target engagement. After the RCT phase, patients continue with open-label treatment in a 6-month follow-up study aiming to assess long-term efficacy and tolerability of pramipexole. Ethics and dissemination The study has been approved by the Swedish Ethical Review Authority and the Swedish Medical Products Agency. The study is externally monitored according to Good Clinical Practice guidelines. Results will be disseminated via conference presentations and peer-reviewed publications.
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Asp, MarieLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups,Skåne University Hospital(Swepub:lu)med-ma10
(author)
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Ståhl, DaryaLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups(Swepub:lu)da6801ty
(author)
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Tjernberg, JohannaLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups,Region Skåne(Swepub:lu)jo0167tj
(author)
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Eklund, MoaLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups,Skåne University Hospital(Swepub:lu)mo0741ek
(author)
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Björkstrand, JohannesLund University,Lunds universitet,Institutionen för psykologi,Samhällsvetenskapliga institutioner och centrumbildningar,Samhällsvetenskapliga fakulteten,Department of Psychology,Departments of Administrative, Economic and Social Sciences,Faculty of Social Sciences(Swepub:lu)jo2676bj
(author)
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van Westen, DanielleLund University,Lunds universitet,Diagnostisk radiologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Diagnostic Radiology, (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)ront-dva
(author)
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Jensen, JimmyKristianstad University(Swepub:lu)extLU-899
(author)
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Månsson, KristofferKarolinska Institute
(author)
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Tornberg, ÅsaLund University,Lunds universitet,Institutionen för hälsovetenskaper,Medicinska fakulteten,Barns och familjers hälsa,Forskargrupper vid Lunds universitet,Department of Health Sciences,Faculty of Medicine,Child and Family Health,Lund University Research Groups(Swepub:lu)fhv-ase
(author)
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Svensson, MartinaLund University,Lunds universitet,Institutionen för experimentell medicinsk vetenskap,Medicinska fakulteten,Neuroinflammation,Forskargrupper vid Lunds universitet,Department of Experimental Medical Science,Faculty of Medicine,Lund University Research Groups(Swepub:lu)med-ms17
(author)
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Deierborg, TomasLund University,Lunds universitet,Institutionen för experimentell medicinsk vetenskap,Medicinska fakulteten,Neuroinflammation,Forskargrupper vid Lunds universitet,Department of Experimental Medical Science,Faculty of Medicine,Lund University Research Groups(Swepub:lu)expb-tol
(author)
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Ventorp, FilipLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups,Skåne University Hospital(Swepub:lu)med-fve
(author)
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Lindqvist, DanielLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Enheten för Biologisk Psykiatri och Precisionspsykiatri,Forskargrupper vid Lunds universitet,Department of Clinical Sciences, Lund,Faculty of Medicine,Unit for Biological and Precision Psychiatry,Lund University Research Groups,Region Skåne(Swepub:lu)med-del
(author)
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Institutionen för kliniska vetenskaper, LundMedicinska fakulteten
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In:BMJ Open: BMJ Publishing Group13:11, s. 92044-6055
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