The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care
Abstract Background The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown...
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| Language: | English |
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BMC
2023-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07361-6 |
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| author | Sibel Saya Patty Chondros Anastasia Abela Cathrine Mihalopolous Mary Lou Chatterton Jane Gunn Timothy F. Chen Thomas M. Polasek Elise Dettmann Rachel Brooks Michelle King Luke Spencer Pavithran Alphonse Shakira Milton Georgia Ramsay Zoe Siviour Jamie Liew Philip Ly Matthew Thoenig Raushaan Seychell Floriana La Rocca Luke B. Hesson Nydia Mejias Terri Sivertsen Melanie Anne Galea Chad Bousman Jon Emery |
| author_facet | Sibel Saya Patty Chondros Anastasia Abela Cathrine Mihalopolous Mary Lou Chatterton Jane Gunn Timothy F. Chen Thomas M. Polasek Elise Dettmann Rachel Brooks Michelle King Luke Spencer Pavithran Alphonse Shakira Milton Georgia Ramsay Zoe Siviour Jamie Liew Philip Ly Matthew Thoenig Raushaan Seychell Floriana La Rocca Luke B. Hesson Nydia Mejias Terri Sivertsen Melanie Anne Galea Chad Bousman Jon Emery |
| author_sort | Sibel Saya |
| collection | DOAJ |
| description | Abstract Background The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs. Methods The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18–65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention. Discussion This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care. Trial registration Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021. |
| first_indexed | 2024-03-13T10:12:31Z |
| format | Article |
| id | doaj.art-55d8406932cd4f07b01ea962249ddd20 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-13T10:12:31Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-55d8406932cd4f07b01ea962249ddd202023-05-21T11:26:20ZengBMCTrials1745-62152023-05-0124111810.1186/s13063-023-07361-6The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary careSibel Saya0Patty Chondros1Anastasia Abela2Cathrine Mihalopolous3Mary Lou Chatterton4Jane Gunn5Timothy F. Chen6Thomas M. PolasekElise Dettmann7Rachel Brooks8Michelle King9Luke Spencer10Pavithran Alphonse11Shakira Milton12Georgia Ramsay13Zoe Siviour14Jamie Liew15Philip Ly16Matthew Thoenig17Raushaan Seychell18Floriana La Rocca19Luke B. Hesson20Nydia Mejias21Terri Sivertsen22Melanie Anne Galea23Chad Bousman24Jon Emery25Department of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneSchool of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash UniversitySchool of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash UniversityDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneSydney Pharmacy School, Faculty of Medicine and Health, The University of SydneyDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneGenetics Department, Douglass Hanly Moir PathologyTranslational SoftwareGenetics Department, Douglass Hanly Moir PathologyGenetics Department, Douglass Hanly Moir PathologyDepartment of Medical Genetics, University of CalgaryDepartment of General Practice and Primary Care, Melbourne Medical School, University of MelbourneAbstract Background The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs. Methods The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18–65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention. Discussion This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care. Trial registration Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.https://doi.org/10.1186/s13063-023-07361-6Major depressive disorderMental healthPharmacogenomicsPrimary careGeneral practiceAntidepressants |
| spellingShingle | Sibel Saya Patty Chondros Anastasia Abela Cathrine Mihalopolous Mary Lou Chatterton Jane Gunn Timothy F. Chen Thomas M. Polasek Elise Dettmann Rachel Brooks Michelle King Luke Spencer Pavithran Alphonse Shakira Milton Georgia Ramsay Zoe Siviour Jamie Liew Philip Ly Matthew Thoenig Raushaan Seychell Floriana La Rocca Luke B. Hesson Nydia Mejias Terri Sivertsen Melanie Anne Galea Chad Bousman Jon Emery The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care Trials Major depressive disorder Mental health Pharmacogenomics Primary care General practice Antidepressants |
| title | The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care |
| title_full | The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care |
| title_fullStr | The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care |
| title_full_unstemmed | The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care |
| title_short | The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care |
| title_sort | preside pharmacogenomics in depression trial a double blind randomised controlled trial of pharmacogenomic informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care |
| topic | Major depressive disorder Mental health Pharmacogenomics Primary care General practice Antidepressants |
| url | https://doi.org/10.1186/s13063-023-07361-6 |
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