Study protocol: combined N-of-1 trials to assess open-label placebo treatment for antidepressant discontinuation symptoms [FAB-study]

BMC Psychiatry

Study Protocol

Claire V. Warren¹  Yvonne Nestoriuc¹  Amke Müller¹  Carina Meißner¹  Tilo Kircher²  Irina Falkenberg²  Stefan Konigorski³  Tahmine Fadai⁴ 

[1] Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Holstenhofweg 85, 22043, Hamburg, Germany;Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany;Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany;Digital Health – Machine Learning Group, Hasso-Plattner-Institute for Digital Engineering, Potsdam, Germany;Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, 10029, New York, NY, USA;Department of Statistics, Harvard University, 150 Western Ave, 02134, Boston, MA, USA;Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany;

关键词: Antidepressant withdrawal;    SSRI;    SNRI;    Side-effects;    Depressive disorder;    N-of-1;    Placebo;    Nocebo;    Treatment expectation;   

DOI  :  10.1186/s12888-023-05184-y

 received in 2023-08-17, accepted in 2023-09-12,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAntidepressant discontinuation is associated with a broad range of adverse effects. Debilitating discontinuation symptoms can impede the discontinuation process and contribute to unnecessary long-term use of antidepressants. Antidepressant trials reveal large placebo effects, indicating a potential use of open-label placebo (OLP) treatment to facilitate the discontinuation process. We aim to determine the effect of OLP treatment in reducing antidepressant discontinuation symptoms using a series of N-of-1 trials.MethodsA series of randomized, single-blinded N-of-1 trials will be conducted in 20 patients with fully remitted DSM-V major depressive disorder, experiencing moderate to severe discontinuation symptoms following antidepressant discontinuation. Each N-of-1 trial consists of two cycles, each comprising two-week alternating periods of OLP treatment and of no treatment in a random order, for a total of eight weeks. Our primary outcome will be self-reported discontinuation symptoms rated twice daily via the smartphone application ‘StudyU’. Secondary outcomes include expectations about discontinuation symptoms and (depressed) mood. Statistical analyses will be based on a Bayesian multi-level random effects model, reporting posterior estimates of the overall and individual treatment effects.DiscussionResults of this trial will provide insight into the clinical application of OLP in treating antidepressant discontinuation symptoms, potentially offering a new cost-effective therapeutic tool. This trial will also determine the feasibility and applicability of a series of N-of-1 trials in a clinical discontinuation trial.Trial registrationClinicalTrials.gov: NCT05051995, first registered September 20, 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 1