UMMS Affiliation
Department of Psychiatry
Publication Date
2019-04-01
Document Type
Article
Disciplines
Health Services Administration | Health Services Research | Medical Pharmacology | Medicinal Chemistry and Pharmaceutics | Mental and Social Health | Mental Disorders | Pharmaceutical Preparations | Pharmacy and Pharmaceutical Sciences | Psychiatry | Therapeutics
Abstract
Current prescribing practices for major depressive disorder (MDD) produce limited treatment success. Although pharmacogenomics may improve outcomes by identifying genetically inappropriate medications, studies to date were limited in scope. Outpatients (N=1167) diagnosed with MDD and with a patient- or clinician-reported inadequate response to at least one antidepressant were enrolled in the Genomics Used to Improve DEpression Decisions (GUIDED) trial - a rater- and patient-blind randomized controlled trial. Patients were randomized to treatment as usual (TAU) or a pharmacogenomics-guided intervention arm in which clinicians had access to a pharmacogenomic test report to inform medication selections (guided-care). Medications were considered congruent ('use as directed' or 'use with caution' test categories) or incongruent ('use with increased caution and with more frequent monitoring' test category) with test results. Unblinding occurred after week 8. Primary outcome was symptom improvement [change in 17-item Hamilton Depression Rating Scale (HAM-D17)] at week 8; secondary outcomes were response ( > /=50% decrease in HAM-D17) and remission (HAM-D17 < /=7) at week 8. At week 8, symptom improvement for guided-care was not significantly different than TAU (27.2% versus 24.4%, p=0.107); however, improvements in response (26.0% versus 19.9%, p=0.013) and remission (15.3% versus 10.1%, p=0.007) were statistically significant. Patients taking incongruent medications prior to baseline who switched to congruent medications by week 8 experienced greater symptom improvement (33.5% versus 21.1%, p=0.002), response (28.5% versus 16.7%, p=0.036), and remission (21.5% versus 8.5%, p=0.007) compared to those remaining incongruent. Pharmacogenomic testing did not significantly improve mean symptoms but did significantly improve response and remission rates for difficult-to-treat depression patients over standard of care (ClinicalTrials.gov NCT02109939).
Keywords
major depressive disorder, pharmacogenomics
Rights and Permissions
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/).
DOI of Published Version
10.1016/j.jpsychires.2019.01.003
Source
J Psychiatr Res. 2019 Apr;111:59-67. doi: 10.1016/j.jpsychires.2019.01.003. Epub 2019 Jan 4. Link to article on publisher's site
Journal/Book/Conference Title
Journal of psychiatric research
Related Resources
PubMed ID
30677646
Repository Citation
Greden JF, Rothschild AJ. (2019). Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study. Open Access Publications by UMMS Authors. https://doi.org/10.1016/j.jpsychires.2019.01.003. Retrieved from https://escholarship.umassmed.edu/oapubs/3832
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Included in
Health Services Administration Commons, Health Services Research Commons, Medical Pharmacology Commons, Medicinal Chemistry and Pharmaceutics Commons, Mental and Social Health Commons, Mental Disorders Commons, Pharmaceutical Preparations Commons, Pharmacy and Pharmaceutical Sciences Commons, Psychiatry Commons, Therapeutics Commons
Comments
Full author list omitted for brevity. For the full list of authors, see article.