Design of a real-world, prospective, longitudinal, observational study to compare vortioxetine with other standard of care antidepressant treatments in patients with major depressive disorder: a PatientsLikeMe survey

BMC Psychiatry

Study Protocol

Sagar V. Parikh¹  Roger S. McIntyre²  Alicia H. McAuliffe-Fogarty³  Mary C. Burke³  Subhara Raveendran³  Deepshikha Singh³  Anit Roy⁴  Michael Martin⁴  Chris Blair⁴  Lambros Chrones⁴  Maggie McCue⁴  Mark G. A. Opler⁵ 

[1] Department of Psychiatry, Michigan Medicine, University of Michigan, 4250 Plymouth Road, 48109, Ann Arbor, MI, USA;Department of Psychiatry, University of Toronto and Centre for Addiction and Mental Health, 1451 Queen Street West, M6R 1A1, Toronto, ON, Canada;University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst St., M5T 2S8, Toronto, ON, Canada;PatientsLikeMe, LLC, 6 Liberty Square, Suite 2602, 02109, Boston, MA, USA;Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Ave, 02421, Lexington, MA, USA;WCG Clinical Endpoint Solutions, 3 Park Avenue, 10016, New York, NY, USA;PANSS Institute, 19 Crotty Court, 10950, Monroe, NY, USA;

关键词: PatientsLikeMe;    Major depressive disorder;    Patient-centric measures;    Goal attainment;    Vortioxetine;    Shared decision-making;   

DOI  :  10.1186/s12888-023-04922-6

 received in 2023-02-06, accepted in 2023-06-03,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMajor depressive disorder (MDD) is a recurrent psychiatric condition that presents challenges in responding to treatment and achieving long-term remission. To improve outcomes, a shared decision-making treatment approach with patient and healthcare practitioner (HCP) engagement is vital. PatientsLikeMe (PLM), a peer community of patients, provides information on MDD, symptoms, and treatment through forums and resources, helping patients stay engaged in their treatment journey. Data on PLM can be harnessed to gain insights into patient perspectives on MDD symptom management, medication switches, and treatment goals and measures.MethodsThis ongoing, decentralized, longitudinal, observational, prospective study is being conducted using the PLM platform in two parts, enrolling up to 500 patients with MDD in the United States aged ≥ 18 years to compare vortioxetine with other monotherapy antidepressants. The first qualitative component consists of a webinar and discussion forum with PLM community members with MDD, followed by a pilot for functionality testing to improve the study flow and questions in the quantitative survey. The quantitative component follows on the PLM platform, utilizing patient-reported assessments, over a 24-week period. Three surveys will be conducted at baseline and weeks 12 and 24 to collect data on patient global impression of improvement, depression severity, cognitive function, quality of life (QoL) and well-being, medication satisfaction, emotional blunting, symptoms of anhedonia and resilience, as well as goal attainment. Quantitative results will be compared between groups. The qualitative component is complete; patient recruitment is underway for the quantitative component, with results expected in late 2023.DiscussionThese results will help HCPs understand patient perspectives on the effectiveness of vortioxetine versus other monotherapy antidepressants in alleviating symptoms of MDD and improvements in QoL. Data from the PLM platform will support a patient goal-based treatment approach, as results can be shared by patients with their HCPs, providing them with insights on patient-centric goals, treatment management and adherence, as well as allowing them to observe changes in patient-related outcomes scores. Findings from the study will also help to optimize the PLM platform to build scalable solutions and connectivity within the community to better serve patients with MDD.

【 授权许可】

CC BY   
© The Author(s) 2023

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