TY - JOUR
T1 - Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR)
T2 - protocol for a randomised, placebo-controlled feasibility trial
AU - Rucker, James
AU - Jafari, Hassan
AU - Mantingh, Tim
AU - Bird, Catherine
AU - Modlin, Nadav Liam
AU - Knight, Gemma
AU - Reinholdt, Frederick
AU - Day, Camilla
AU - Carter, Ben
AU - Young, Allan
N1 - Funding Information:
Funding The trial is funded by the Clinician Scientist Programme (CS-2017-17-007) from the National Institute for Health Research (NIHR). Psilocybin and placebo capsules are provided without charge by COMPASS Pathways. This work presents independent research part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. No award/grant number is applicable.
Funding Information:
Competing interests JR is an honorary consultant psychiatrist at The South London & Maudsley NHS Foundation Trust, a consultant psychiatrist at Sapphire Medical Clinics and an NIHR Clinician Scientist Fellow at the Centre for Affective Disorders at King’s College London. JR’s salary is funded by a fellowship (CS-2017-17-007) from the National Institute for Health Research (NIHR). JR leads the Psychedelic Trials Group with Professor Allan Young at King’s College London. King’s College London receives grant funding from COMPASS Pathways PLC and Beckley PsyTech to undertake phase 1 and phase 2 trials with psychedelics, including psilocybin. COMPASS Pathways PLC has paid for James Rucker to attend trial related meetings and conferences to present the results of research using psilocybin. COMPASS Pathways provided the psilocybin and placebo capsules for this trial, without charge. JR asserts that COMPASS Pathways had no influence over the content of this article or the design of this trial. JR has undertaken paid consultancy work for Beckley PsyTech and Clerkenwell Health. Payments for consultancy work are received and managed by King’s College London. James Rucker does not benefit personally. JR has no shareholdings in pharmaceutical companies. Allan H Young. Employed by King’s College London; Honorary Consultant SLaM (NHS UK). Paid lectures and advisory boards for the following companies with drugs used in affective and related disorders: Astrazenaca, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, COMPASS. Consultant to Johnson & Johnson. Consultant to Livanova. Received honoraria for attending advisory boards and presenting talks at meetings organised by LivaNova. Principal Investigator in the Restore-Life VNS registry study funded by LivaNova. Principal Investigator on ESKETINTRD3004: 'An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression'. Principal Investigator on 'The Effects of Psilocybin on Cognitive Function in Healthy Participants'. Principal Investigator on 'The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)'. Grant funding (past and present): NIMH (USA); CIHR (Canada); NARSAD (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians (Edin); BMA (UK); UBC-VGH Foundation (Canada); WEDC (Canada); CCS Depression Research Fund (Canada); MSFHR (Canada); NIHR (UK). Janssen (UK). No shareholdings in pharmaceutical companies. All other authors declare no competing interests.
Publisher Copyright:
©
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85121244399&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-056091
DO - 10.1136/bmjopen-2021-056091
M3 - Article
C2 - 34853114
SN - 2044-6055
VL - 11
SP - e056091
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e056091
ER -