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dc.contributor.authorDunlop, Boadie W.
dc.contributor.authorParikh, Sagar V.
dc.contributor.authorRothschild, Anthony J.
dc.contributor.authorThase, Michael E.
dc.contributor.authorDeBattista, Charles
dc.contributor.authorConway, Charles R.
dc.contributor.authorForester, Brent P.
dc.contributor.authorMondimore, Francis M.
dc.contributor.authorShelton, Richard C.
dc.contributor.authorMacaluso, Matthew
dc.contributor.authorLogan, Jennifer
dc.contributor.authorTraxler, Paul
dc.contributor.authorLi, James
dc.contributor.authorJohnson, Holly
dc.contributor.authorGreden, John F.
dc.date2022-08-11T08:09:55.000
dc.date.accessioned2022-08-23T16:48:34Z
dc.date.available2022-08-23T16:48:34Z
dc.date.issued2019-12-27
dc.date.submitted2020-01-02
dc.identifier.citation<p>BMC Psychiatry. 2019 Dec 27;19(1):420. doi: 10.1186/s12888-019-2410-2. <a href="https://doi.org/10.1186/s12888-019-2410-2">Link to article on publisher's site</a></p>
dc.identifier.issn1471-244X (Linking)
dc.identifier.doi10.1186/s12888-019-2410-2
dc.identifier.pmid31881956
dc.identifier.urihttp://hdl.handle.net/20.500.14038/41299
dc.description.abstractBACKGROUND: Previous research suggests that the 17-item Hamilton Depression Rating Scale (HAM-D17) is less sensitive in detecting differences between active treatment and placebo for major depressive disorder (MDD) than is the HAM-D6 scale, which focuses on six core depression symptoms. Whether HAM-D6 shows greater sensitivity when comparing two active MDD treatment arms is unknown. METHODS: This post hoc analysis used data from the intent-to-treat (ITT) cohort (N = 1541) of the Genomics Used to Improve DEpression Decisions (GUIDED) trial, a rater- and patient-blinded randomized controlled trial. GUIDED compared combinatorial pharmacogenomics-guided care with treatment as usual (TAU) in patients with MDD. Percent of symptom improvement, response rate and remission rate from baseline to week 8 were evaluated using both scales. Analyses were performed for the full cohort and for the subset of patients who at baseline were taking medications predicted by the test to have moderate or significant gene-drug interactions. A Mokken scale analysis was conducted to compare the homogeneity of HAM-D17 with that of HAM-D6. RESULTS: At week 8, the guided-care arm demonstrated statistically significant benefit over TAU when the HAM-D6 ( = 4.4%, p = 0.023) was used as the continuous measure of symptom improvement, but not when using the HAM-D17 ( = 3.2%, p = 0.069). Response rates increased significantly for guided-care compared with TAU when evaluated using both HAM-D6 ( = 7.0%, p = 0.004) and HAM-D17 ( = 6.3%, p = 0.007). Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 = 4.6%, p = 0.031; HAM-D17 = 5.5%, p = 0.005). Patients in the guided-care arm who at baseline were taking medications predicted to have gene-drug interactions showed further increased benefit over TAU at week 8 for symptom improvement ( = 7.3%, p = 0.004) response ( = 10.0%, p = 0.001) and remission ( = 7.9%, p = 0.005) using HAM-D6. All outcomes showed continued improvement through week 24. Mokken scale analysis demonstrated the homogeneity and unidimensionality of HAM-D6, but not of HAM-D17, across treatment arms. CONCLUSIONS: The HAM-D6 scale identified a statistically significant difference in symptom improvement between combinatorial pharmacogenomics-guided care and TAU, whereas the HAM-D17 did not. The demonstrated utility of pharmacogenomics-guided treatment over TAU as detected by the HAM-D6 highlights its value for future biomarker-guided trials comparing active treatment arms. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02109939. Registered 10 April 2014.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=31881956&dopt=Abstract">Link to Article in PubMed</a></p>
dc.rights© The Author(s). 2019 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectAntidepressant
dc.subjectAssessment
dc.subjectBiomarker
dc.subjectClinical trial
dc.subjectClinical utility
dc.subjectComparative effectiveness
dc.subjectDecision-making
dc.subjectDepression
dc.subjectGenetics
dc.subjectPharmacogenomics
dc.subjectClinical Trials
dc.subjectGenetic Phenomena
dc.subjectGenetics
dc.subjectMental Disorders
dc.subjectPsychiatry
dc.subjectPsychological Phenomena and Processes
dc.titleComparing sensitivity to change using the 6-item versus the 17-item Hamilton depression rating scale in the GUIDED randomized controlled trial
dc.typeArticle
dc.source.journaltitleBMC psychiatry
dc.source.volume19
dc.source.issue1
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=5104&amp;context=oapubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/oapubs/4085
dc.identifier.contextkey16101187
refterms.dateFOA2022-08-23T16:48:34Z
html.description.abstract<p>BACKGROUND: Previous research suggests that the 17-item Hamilton Depression Rating Scale (HAM-D17) is less sensitive in detecting differences between active treatment and placebo for major depressive disorder (MDD) than is the HAM-D6 scale, which focuses on six core depression symptoms. Whether HAM-D6 shows greater sensitivity when comparing two active MDD treatment arms is unknown.</p> <p>METHODS: This post hoc analysis used data from the intent-to-treat (ITT) cohort (N = 1541) of the Genomics Used to Improve DEpression Decisions (GUIDED) trial, a rater- and patient-blinded randomized controlled trial. GUIDED compared combinatorial pharmacogenomics-guided care with treatment as usual (TAU) in patients with MDD. Percent of symptom improvement, response rate and remission rate from baseline to week 8 were evaluated using both scales. Analyses were performed for the full cohort and for the subset of patients who at baseline were taking medications predicted by the test to have moderate or significant gene-drug interactions. A Mokken scale analysis was conducted to compare the homogeneity of HAM-D17 with that of HAM-D6.</p> <p>RESULTS: At week 8, the guided-care arm demonstrated statistically significant benefit over TAU when the HAM-D6 ( = 4.4%, p = 0.023) was used as the continuous measure of symptom improvement, but not when using the HAM-D17 ( = 3.2%, p = 0.069). Response rates increased significantly for guided-care compared with TAU when evaluated using both HAM-D6 ( = 7.0%, p = 0.004) and HAM-D17 ( = 6.3%, p = 0.007). Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 = 4.6%, p = 0.031; HAM-D17 = 5.5%, p = 0.005). Patients in the guided-care arm who at baseline were taking medications predicted to have gene-drug interactions showed further increased benefit over TAU at week 8 for symptom improvement ( = 7.3%, p = 0.004) response ( = 10.0%, p = 0.001) and remission ( = 7.9%, p = 0.005) using HAM-D6. All outcomes showed continued improvement through week 24. Mokken scale analysis demonstrated the homogeneity and unidimensionality of HAM-D6, but not of HAM-D17, across treatment arms.</p> <p>CONCLUSIONS: The HAM-D6 scale identified a statistically significant difference in symptom improvement between combinatorial pharmacogenomics-guided care and TAU, whereas the HAM-D17 did not. The demonstrated utility of pharmacogenomics-guided treatment over TAU as detected by the HAM-D6 highlights its value for future biomarker-guided trials comparing active treatment arms.</p> <p>TRIAL REGISTRATION: Clinicaltrials.gov: NCT02109939. Registered 10 April 2014.</p>
dc.identifier.submissionpathoapubs/4085
dc.contributor.departmentDepartment of Psychiatry
dc.source.pages420


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© The Author(s). 2019 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Except where otherwise noted, this item's license is described as © The Author(s). 2019 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.