A Randomized Controlled Trial of Combinatorial Pharmacogenetics Testing in Adolescent Depression - 20/12/21
, Scott S. Orth, DO, Julia Shekunov, MD, Magdalena Romanowicz, MD, Jennifer R. Geske, MS, Jessica A. Ward, BA, Nicole I. Leibman, MD, Mark A. Frye, MD, Paul E. Croarkin, DO, MSRésumé |
Objective |
Numerous commercial pharmacogenetics panels are now widely available for clinical use in psychiatric practice. However, there is a paucity of literature evaluating the use of combinatorial pharmacogenetics panels to enhance outcomes in the treatment of adolescents with depression. This study sought to prospectively evaluate the clinical impact of combinatorial pharmacogenetics testing in a double-blind, randomized, controlled effectiveness study for the pharmacologic treatment of adolescents with depression.
Method |
Adolescents aged 13 to 18 years (N = 176) with moderate to severe major depressive disorder (MDD) were randomized to treatment arm guided by testing in which pharmacogenetic testing results were available at the baseline visit (GENE arm, n = 84) or a treatment-as-usual arm (TAU arm, n = 92) in which testing results were not available until an 8-week visit. Raters, participants, and families were blinded to group allocation. Symptom improvement, side effects, and satisfaction were assessed throughout the study at 4 weeks, 8 weeks, and 6 months.
Results |
There were no differences between the GENE and TAU arms at 8 weeks or 6 months for symptom improvement, side effect burden, or satisfaction. Selective serotonin reuptake inhibitors were prescribed at higher rates in the TAU arm compared to the GENE arm (p = .024).
Conclusion |
Combinatorial pharmacogenetics−guided treatment did not demonstrate improved outcomes compared to TAU in adolescents with MDD. Future research should examine how specific medication−gene pairs may affect clinical outcomes in the treatment of adolescents with depression and how best to integrate pharmacogenetics into clinical practice.
Clinical trial registration information |
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression; www.clinicaltrials.gov; NCT02286440.
Le texte complet de cet article est disponible en PDF.Key words : pharmacogenetics testing, randomized, double-blind, depression
Plan
| Funding for this study was primarily provided by the Mayo Clinic Center for Individualized Medicine. In addition, Drs. Vande Voort and Croarkin were co-primary investigators on this investigator-initiated study that had a grant-in-kind for supplies and genotyping only through Assurex Health, Inc. Assurex Health, Inc. did not have any role in the development or design of the study, collection of data, statistical analysis, interpretation of data, writing of the manuscript, or decision for publication of this study. |
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| Consent has been provided for descriptions of specific patient information. |
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| This study was presented at the American Academy of Child and Adolescent Psychiatry 66th Annual Meeting; October 14-19, 2019; Chicago, Illinois. |
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| Ms. Geske served as the statistical expert for this research. |
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| Author Contributions Conceptualization: Vande Voort, Geske, Frye, Croarkin Data curation: Vande Voort, Orth, Shekunov, Ward, Croarkin Formal analysis: Vande Voort, Geske, Frye, Croarkin Funding acquisition: Frye, Croarkin Investigation: Vande Voort, Orth, Shekunov, Romanowicz, Ward, Frye, Croarkin Methodology: Vande Voort, Geske, Frye, Croarkin Project administration: Vande Voort, Orth, Shekunov, Ward, Frye, Croarkin Resources: Frye, Croarkin Supervision: Vande Voort, Orth, Shekunov, Romanowicz, Geske, Frye, Croarkin Validation: Vande Voort, Croarkin Writing – original draft: Vande Voort, Geske, Croarkin Writing – review and editing: Vande Voort, Orth, Shekunov, Romanowicz, Geske, Ward, Leibman, Frye, Croarkin |
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| The authors gratefully thank the participants and their families who participated in this study. |
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| Disclosure: All authors are currently employed or have been employed by the Mayo Clinic, which had a prior financial interest in Assurex Health, Inc. and currently has a financial interest in OneOme and the technology referenced with this publication. Dr. Vande Voort has served as a site primary investigator for a multicenter study funded by the National Networks of Depression Centers. Dr. Leibman has received grant funding through the National Institute of General Medical Sciences of the National Institutes of Health (NIH; T32 GM008685). Dr. Frye has received grant funding through the Mayo Foundation, Medibio, and Assurex Health, Inc. He has been a consultant for Actify Neurotherapies, Allergan, Intra-Cellular Therapies, Inc., Janssen, Myriad, Neuralstem Inc., Sanofi, Takeda, and Teva Pharmaceuticals. He has received CME/travel/honoraria through American Physician Institute, CME Outfitters, and Global Academy for Medical Education. Dr. Croarkin has received research support from NIH. He has received research grant support from Pfizer, Inc. and equipment support from Neuronetics, Inc. and MagVenture, Inc. He has been the primary investigator for a multicenter study funded by Neuronetics, Inc. and a site primary investigator for a study funded by NeoSync, Inc. He has served as a paid consultant for Procter and Gamble Company and Myriad Neuroscience. Drs. Orth, Shekunov, Romanowicz and Mss. Geske and Ward have reported no biomedical financial interests or potential conflicts of interest. |
Vol 61 - N° 1
P. 46-55 - janvier 2022 Retour au numéro
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