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Abstract
Background
Post-COVID-19 condition (PCC), also known as "long COVID," is characterized by persistent symptoms, negatively affecting the well-being of individuals with PCC. Anhedonia (i.e. reduced capacity for pleasure) and compromised psychosocial functioning are notable symptoms in those with PCC. We aimed to provide insights to understand the effects of anhedonia and impaired psychosocial functioning of individuals with PCC.
Methods
This post-hoc analysis used data from an 8-week, double-blind, randomized, placebo-controlled trial which evaluated vortioxetine for cognitive deficits in individuals with PCC (Clinicaltrials.gov Identifier: NCT05047952). A total of 147 eligible participants were randomly assigned to receive vortioxetine or matching placebo over eight weeks of double-blind treatment. Our study investigated the relationship between anhedonia, assessed by the Snaith-Hamilton Pleasure Scale (SHAPS), and psychosocial functioning, measured with the Post-COVID Functional Status (PCFS) scale. The analysis was conducted using a generalized linear model, with adjustments for relevant covariates such as age, sex, education, suspected versus confirmed COVID diagnosis, MDD diagnosis, and alcohol consumption.
Results
Of the 147 participants, 143 participants had available baseline data for analysis. We observed that baseline PCFS score was statistically significantly positively correlated to baseline SHAPS score (β = 0.070, p = 0.045, 95% CI).
Discussions
Our analysis revealed a significant relationship between measures of anhedonia and psychosocial functioning in adults with PCC. Strategies that aim to improve patient-reported outcomes with PCC need to prioritize the prevention and treatment of hedonic disturbances in patients experiencing PCC.
Transparency
Declaration of funding
The primary clinical trial was sponsored by the Brain and Cognition Discovery Foundation (BCDF) through an unrestricted research grant from H. Lundbeck A/S, Copenhagen, Denmark. BCDF functions as a non-profit research organization. No specific grant from public, commercial, or not-for-profit funding organizations was given to the authors of this post hoc analysis.
Declaration of financial/other relationships
Roger S. McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals,Viatris, Abbvie, Atai Life Sciences. Dr. Roger McIntyre is a CEO of Braxia Scientific Corp. Kayla M. Teopiz has received fees from Braxia Scientific Corp. Taeho Greg Rhee was supported in part by the National Institute on Aging (#R21AG070666; R21AG078972; R01AG088647), National Institute of Mental Health (#R01MH131528), and National Institute on Drug Abuse (#R21DA057540). Dr. Rhee serves as a review committee member for Patient-Centered Outcomes Research Institute (PCORI) and Substance Abuse and Mental Health Services Administration (SAMHSA) and has received honoraria payments from PCORI and SAMHSA. Dr. Rhee has also served as a stakeholder/consultant for PCORI and received consulting fees from PCORI. Dr. Rhee serves as an advisory committee member for International Alliance of Mental Health Research Funders (IAMHRF). Dr. Rhee is currently a co-Editor-in-Chief of Mental Health Science and has received honorarium payments annually from the publisher, John Wiley & Sons, Inc. Roger Ho has received National University of Singapore iHeathtech Other Operating Expenses (A-0001415-09-00). All other authors have nothing to disclose. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
RSM conceptualized the hypothesis, design and methodology of the primary clinical trial. SL and RSM conceptualized the current post hoc analysis including hypothesis and methodology. Material preparation and data collection was performed by SL and ATHK. Data analysis was performed by ATHK. GHL, and SL prepared and and Supplementary Table 1. The first draft of the manuscript was written by SL and RSM. All authors contributed to revisions of the manuscript. All authors read and approved the final manuscript.
Acknowledgements
The post hoc analysis presented herein utilized data from a primary study sponsored by the Brain and Cognition Discovery Foundation (BCDF), a non-profit organization based in Toronto, Ontario, Canada. The authors express gratitude to the volunteers and staff at BCDF for their assistance in data management and administrative support.
Data availability statement
The data disclosed in this study are accessible upon request to the corresponding author.
Ethical statement
The study protocol received approval from Advarra, a local research ethics board adhering to Health Canada regulations, under IRB#00000971. Furthermore, the clinical trial is registered on Clinicaltrials.gov with the identifier NCT05047952. Throughout the conduct of the clinical trial, adherence to the Declaration of Helsinki and Good Clinical Practice guidelines was strictly maintained. Prior to their participation in the study, each participant provided written, informed consent, ensuring ethical compliance and respect for participant autonomy.