{"id":27,"date":"2021-07-20T05:00:36","date_gmt":"2021-07-20T05:00:36","guid":{"rendered":"https:\/\/www.alignedstudy.org.au\/?page_id=27"},"modified":"2023-06-23T12:44:19","modified_gmt":"2023-06-23T01:44:19","slug":"for-health-professionals","status":"publish","type":"page","link":"https:\/\/www.alignedstudy.org.au\/index.php\/for-health-professionals\/","title":{"rendered":"Information for Healthcare Professionals"},"content":{"rendered":"\t\t
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The ALIGNED study is an investigator-initiated, randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with moderate to severe depression.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Pharmacogenomics (PG) is the study of how genetic variations affect an individual\u2019s likely response to therapeutic medications. Other potential biomarkers identified will be integrated with PG via machine learning to develop a predictive model of treatment response. PG-guided therapy has the potential to offer a more effective precision approach to treatment selection.<\/div>
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Study participants are randomised to either the pharmacogenomics-guided intervention arm or a standard care (control) arm. The prescribing doctors of all participants are provided with a treatment guide to inform prescription of antidepressant therapy. Prescribers in the intervention arm\u00a0will receive a treatment guide informed by their patient\u2019s pharmacogenomic analysis, whereas prescribers in the control arm will receive a treatment guide in line with best practice (not informed by their patient\u2019s pharmacogenomics).\u00a0<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The ALIGNED study is double-blind, with both prescribing doctors and participants blinded to treatment allocation.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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At week 12 of the study, unblinding will take place, where both prescribing doctors and participants will be informed of treatment allocation. All prescribing doctors of participants will then receive a direct copy of the participant\u2019s pharmacogenomic report issued by a NATA-accredited laboratory. The report contains pharmacogenomics information for psychotropic as well as other medications that can be used in the future.<\/p>

Potential study participants will be screened using the DSM-5 MINI assessment to establish a diagnosis of major depressive disorder and the Montgomery-\u00c5sberg Depression Rating Scale (MADRS) to determine depression severity. Following confirmation of major depressive disorder, baseline study assessments and randomisation will take place.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The study comprises 4 sessions (teleconference or phone call) with participants and will take approximately 3 months (12 weeks).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Register a patient for possible study participation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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If you would like to register a patient for possible study participation, please contact the Central Coordinating Centre<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tContact Central Coordinating Centre<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

The ALIGNED study is an investigator-initiated, randomised-controlled trial of pharmacogenomics-guided therapy versus standard care for people with moderate to severe depression. Pharmacogenomics (PG) is the study of how genetic variations affect an individual\u2019s likely response to therapeutic medications. Other potential biomarkers identified will be integrated with PG via machine learning to develop a predictive model […]<\/p>\n","protected":false},"author":5,"featured_media":365,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"class_list":["post-27","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/pages\/27","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/comments?post=27"}],"version-history":[{"count":41,"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/pages\/27\/revisions"}],"predecessor-version":[{"id":1152,"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/pages\/27\/revisions\/1152"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/media\/365"}],"wp:attachment":[{"href":"https:\/\/www.alignedstudy.org.au\/index.php\/wp-json\/wp\/v2\/media?parent=27"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}