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
Abstract Background Major 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 i...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-06-01
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| Series: | BMC Psychiatry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12888-023-04922-6 |
| _version_ | 1797789650078662656 |
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| author | Subhara Raveendran Deepshikha Singh Mary C. Burke Alicia H. McAuliffe-Fogarty Sagar V. Parikh Roger S. McIntyre Anit Roy Michael Martin Lambros Chrones Mark G. A. Opler Chris Blair Maggie McCue |
| author_facet | Subhara Raveendran Deepshikha Singh Mary C. Burke Alicia H. McAuliffe-Fogarty Sagar V. Parikh Roger S. McIntyre Anit Roy Michael Martin Lambros Chrones Mark G. A. Opler Chris Blair Maggie McCue |
| author_sort | Subhara Raveendran |
| collection | DOAJ |
| description | Abstract Background Major 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. Methods This 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. Discussion These 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. |
| first_indexed | 2024-03-13T01:53:41Z |
| format | Article |
| id | doaj.art-9e84ff1d3fe54217bb30df4f829bdf54 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-03-13T01:53:41Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-9e84ff1d3fe54217bb30df4f829bdf542023-07-02T11:22:36ZengBMCBMC Psychiatry1471-244X2023-06-0123111310.1186/s12888-023-04922-6Design 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 surveySubhara Raveendran0Deepshikha Singh1Mary C. Burke2Alicia H. McAuliffe-Fogarty3Sagar V. Parikh4Roger S. McIntyre5Anit Roy6Michael Martin7Lambros Chrones8Mark G. A. Opler9Chris Blair10Maggie McCue11PatientsLikeMe, LLCPatientsLikeMe, LLCPatientsLikeMe, LLCPatientsLikeMe, LLCDepartment of Psychiatry, Michigan Medicine, University of MichiganDepartment of Psychiatry, University of Toronto and Centre for Addiction and Mental HealthTakeda Pharmaceuticals U.S.A., Inc.Takeda Pharmaceuticals U.S.A., Inc.Takeda Pharmaceuticals U.S.A., Inc.WCG Clinical Endpoint SolutionsTakeda Pharmaceuticals U.S.A., Inc.Takeda Pharmaceuticals U.S.A., Inc.Abstract Background Major 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. Methods This 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. Discussion These 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.https://doi.org/10.1186/s12888-023-04922-6PatientsLikeMeMajor depressive disorderPatient-centric measuresGoal attainmentVortioxetineShared decision-making |
| spellingShingle | Subhara Raveendran Deepshikha Singh Mary C. Burke Alicia H. McAuliffe-Fogarty Sagar V. Parikh Roger S. McIntyre Anit Roy Michael Martin Lambros Chrones Mark G. A. Opler Chris Blair Maggie McCue 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 PatientsLikeMe Major depressive disorder Patient-centric measures Goal attainment Vortioxetine Shared decision-making |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | PatientsLikeMe Major depressive disorder Patient-centric measures Goal attainment Vortioxetine Shared decision-making |
| url | https://doi.org/10.1186/s12888-023-04922-6 |
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