Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial
Introduction Psilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this t...
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e056091.full |
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| author | Ben Carter Allan Young James Rucker Catherine Bird Gemma Knight Hassan Jafari Tim Mantingh Nadav Liam Modlin Frederick Reinholdt Camilla Day |
| author_facet | Ben Carter Allan Young James Rucker Catherine Bird Gemma Knight Hassan Jafari Tim Mantingh Nadav Liam Modlin Frederick Reinholdt Camilla Day |
| author_sort | Ben Carter |
| collection | DOAJ |
| description | Introduction Psilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.Methods and analysis We are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25 mg of psilocybin.Ethics and dissemination All participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO/0206), Health Research Authority (252750) and Medicine’s and Healthcare Products Regulatory Agency (CTA 14523/0284/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media.Trial registration numbers EUDRACT2018-003573-97; NCT04959253. |
| format | Article |
| id | doaj-art-81bc2104b54d4bbea76aeb78a2a7ceed |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
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| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-81bc2104b54d4bbea76aeb78a2a7ceed2025-08-20T02:48:45ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-056091Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trialBen Carter0Allan Young1James Rucker2Catherine Bird3Gemma Knight4Hassan Jafari5Tim Mantingh6Nadav Liam Modlin7Frederick Reinholdt8Camilla Day93 Department of Biostatistics and Health informatics, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UKCentre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry Psychology and Neuroscience, King’s College London, London, UKSouth London and Maudsley NHS Foundation Trust and Kings College LondonDepartment of Psychological Medicine, Kings College London, London, UK1Centre for Health, and Injury and Illness Prevention in Sport, University of Bath, Bath, UKDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King`s College London, London, UKDepartment of Psychological Medicine, Kings College London, London, UKDepartment of Psychological Medicine, Kings College London, London, UKDepartment of Psychological Medicine, Kings College London, London, UKDepartment of Psychological Medicine, Kings College London, London, UKIntroduction Psilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.Methods and analysis We are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25 mg of psilocybin.Ethics and dissemination All participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO/0206), Health Research Authority (252750) and Medicine’s and Healthcare Products Regulatory Agency (CTA 14523/0284/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media.Trial registration numbers EUDRACT2018-003573-97; NCT04959253.https://bmjopen.bmj.com/content/11/12/e056091.full |
| spellingShingle | Ben Carter Allan Young James Rucker Catherine Bird Gemma Knight Hassan Jafari Tim Mantingh Nadav Liam Modlin Frederick Reinholdt Camilla Day Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial BMJ Open |
| title | Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial |
| title_full | Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial |
| title_fullStr | Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial |
| title_full_unstemmed | Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial |
| title_short | Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial |
| title_sort | psilocybin assisted therapy for the treatment of resistant major depressive disorder psider protocol for a randomised placebo controlled feasibility trial |
| url | https://bmjopen.bmj.com/content/11/12/e056091.full |
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