Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial - 20/12/21
, Ella E. Thompson, BA a, Robert J. Hilt, MD b, Nadine Schwartz, MD c, Adelaide S. Robb, MD d, Christoph U. Correll, MD e, Douglas Newton, MD f, Kelly Rogalski, MD g, Marian F. Earls, MD h, Robert A. Kowatch, MD c, Arne Beck, PhD i, Bobbi Jo H. Yarborough, PsyD j, Stephen Crystal, PhD k, Benedetto Vitiello, MD l, Kelly J. Kelleher, MD, MPH c, Gregory E. Simon, MD aRésumé |
Objective |
To develop a new approach to prescribing guidelines as part of a pragmatic trial, Safer Use of Antipsychotics in Youth (SUAY; ClinicalTrials.gov Identifier: NCT03448575), which supports prescribers in delivering high-quality mental health care to youths.
Method |
A nominal group technique was used to identify first- to nth-line treatments for target symptoms and potential diagnoses. The panel included US pediatricians, child and adolescent psychiatrists, and psychopharmacology experts. Meeting materials included information about Medicaid review programs, systematic reviews, prescribing guidelines, and a description of the pragmatic trial. Afterward, a series of 4 webinar discussions were held to achieve consensus on recommendations.
Results |
The panel unanimously agreed that the guideline should focus on target symptoms rather than diagnoses. Guidance included recommendations for first- to nth-line treatment of target mental health symptoms, environmental factors to be addressed, possible underlying diagnoses that should first be considered and ruled out, and general considerations for pharmacological and therapeutic treatments.
Conclusion |
Prescribing guidelines are often ignored because they do not incorporate the real-world availability of first-line psychosocial treatments, comorbid conditions, and clinical complexity. Our approach addresses some of these concerns. If the approach proves successful in our ongoing pragmatic trial, Safer Use of Antipsychotics in Youth (SUAY), it may serve as a model to state Medicaid programs and health systems to support clinicians in delivering high-quality mental health care to youths.
Clinical trial registration information |
Safer Use of Antipsychotics in Youth; clinicaltrials.gov/; NCT03448575
Le texte complet de cet article est disponible en PDF.Key words : antipsychotic, guidelines, consulting, accessibility
Plan
| This project is supported by the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH) under contract number HHSN271201600002C (Penfold) “A Targeted Approach to a Safer Use of Antipsychotics in Youth” (total award $9,658,552; no project costs were financed by nongovernmental sources). This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by NIMH or NIH. Dr. Crystal's work is supported by the Agency for Healthcare Research and Quality 1R01HS026001 and R18HS03258, the Patient-Centered Outcomes Research Institute HSA2902010000101, and the National Center for Advancing Translational Sciences (NCATS) UL1TR003017. |
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| The research was performed with permission from Kaiser Permanente Washington Health Research Institute's Institutional Review Board. |
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| Author Contributions |
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| Conceptualization: Penfold, Hilt, Correll, Beck, Crystal, Vitiello, Kelleher, Simon |
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| Data curation: Thompson |
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| Funding acquisition: Penfold, Vitiello, Kelleher, Simon |
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| Investigation: Hilt, Robb, Correll, Newton, Rogalski, Earls, Kowatch, Crystal, Simon |
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| Methodology: Beck |
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| Project administration: Thompson |
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| Resources: Thompson |
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| Writing – original draft: Penfold, Thompson |
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| Writing – review and editing: Hilt, Schwartz, Robb, Correll, Newton, Rogalski, Earls, Kowatch, Beck, Yarborough, Crystal, Vitiello, Kelleher, Simon |
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| The authors wish to thank Adam Haim, PhD, of NIMH, for his critical input to the design and conduct of the study. They also thank Galia Siegal, PhD, of the Clinical Trials Operations Branch at NIMH, for her invaluable assistance in coordinating the clinical trial and liaising with the DSMB. |
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| Disclosure: Dr. Schwartz has been a consultant for the law firm Drinker, Biddle and Reath, now known as Faegre, Drinker, Biddle and Reath, in the past two years. She holds no stocks of pharmaceutical companies. Dr. Robb has been a consultant and/or advisor to or has received honoraria from the American Academy of Child and Adolescent Psychiatry, the American Academy of Pediatrics, I-ACT, Lundbeck/Takeda, the Neuroscience Education Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Supernus. She has served on a Data Safety Monitoring Board for NIMH and Otsuka. She has received grant support from NCATS, NIMH, Actavis/Forest/Allergan, Lundbeck/Takeda, and Supernus. She has IRA stock in Eli Lilly and Co., GlaxoSmithKline, Johnson and Johnson, and Pfizer. Dr. Correll has been a consultant and/or advisor to or has received honoraria from Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, IntraCellular Therapies, Janssen/JandJ, Karuna, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Medscape, Merck, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Servier, Sumitomo Dainippon, Sunovion, Supernus, Takeda, and Teva. He has provided expert testimony for Janssen and Otsuka. He has served on a Data Safety Monitoring Board for Lundbeck, Rovi, Supernus, and Teva. He has received grant support from Janssen and Takeda. He is a stock option holder of LB Pharma. Dr. Vitiello has been a consultant for Medice, Lundbeck, Angelini, and Alkermes Pharmaceuticals, and for law firms Goodwin and Procter and Haynes and Boone, in the past two years. He holds no stocks of pharmaceutical companies. Drs. Penfold, Hilt, Newton, Rogalski, Earls, Kowatch, Beck, Yarborough, Crystal, Kelleher, Simon, and Ms. Thompson have reported no biomedical financial interests or potential conflicts of interest. |
Vol 61 - N° 1
P. 93-102 - janvier 2022 Retour au numéro
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