Severely Aggressive Children Receiving Stimulant Medication Versus Stimulant and Risperidone: 12-Month Follow-Up of the TOSCA Trial - 28/05/16
, Nicole V. Brown, MS b, L. Eugene Arnold, MEd, MD c, Kristin A. Buchan-Page, BA c, Oscar G. Bukstein, MD, MPH f, Eric Butter, PhD c, Cristan A. Farmer, PhD d, Robert L. Findling, MD, MBA g, David J. Kolko, PhD e, Brooke S.G. Molina, PhD e, Robert R. Rice, PhD c, Jayne Schneider, PhD a, Michael G. Aman, PhD cAbstract |
Objective |
The objective of this study was to evaluate 52-week clinical outcomes of children with co-occurring attention-deficit/hyperactivity disorder (ADHD), disruptive behavior disorder, and serious physical aggression who participated in a prospective, longitudinal study that began with a controlled, 9-week clinical trial comparing the relative efficacy of parent training + stimulant medication + placebo (Basic; n = 84) versus parent training + stimulant + risperidone (Augmented; n = 84).
Method |
Almost two-thirds (n = 108; 64%) of families in the 9-week study participated in week 52 follow-ups (Basic, n = 55; Augmented, n = 53) and were representative of the initial study sample. The assessment battery included caregiver and clinician ratings and laboratory tests.
Results |
Only 43% of participants in the Augmented group and 36% in the Basic group still adhered to their assigned regimen (not significant [NS]); 23% of those in the Augmented group and 11% in the Basic group were taking no medication (NS). Both randomized groups improved baseline to follow-up, but the 3 primary parent-reported behavioral outcomes showed no significant between-group differences. Exploratory analyses indicated that participants in the Augmented group (65%) were more likely (p = .02) to have a Clinical Global Impressions (CGI) severity score of 1 to 3 (i.e., normal to mildly ill) at follow-up than those in the Basic group (42%). Parents rated 45% of children as impaired often or very often from ADHD, noncompliant, or aggressive behavior. The Augmented group had elevated prolactin levels, and the Basic group had decreased weight over time. Findings were generally similar whether groups were defined by randomized assignment or follow-up treatment status.
Conclusion |
Both treatment strategies were associated with clinical improvement at follow-up, and primary behavioral outcomes did not differ significantly. Many children evidenced lingering mental health concerns, suggesting the need for additional research into more effective interventions.
Clinical trial registration information—Treatment of Severe Childhood Aggression (the TOSCA Study); clinicaltrials.gov/; NCT00796302
Le texte complet de cet article est disponible en PDF.Key words : ADHD, oppositional defiant disorder, conduct disorder, risperidone, methylphenidate
Plan
| Clinical guidance is available at the end of this article. |
|
| This study was supported by grants from NIMH to The Ohio State University (R01 MH077907), Case Western Reserve University (R01 MH077750), the University of Pittsburgh (R01 MH077676), and Stony Brook University (R01MH 077997). The project was supported by a National Institutes of Health (NIH) General Clinical Research Center grant M01RR10710 (Stony Brook University) and Clinical and Translational Science Awards from the National Center for Advancing Translational Sciences: grants 8UL1TR000090-05 (The Ohio State University) and UL1 RR024153 and UL1TR000005 (University of Pittsburgh). |
|
| The content is solely the responsibility of the authors and does not necessarily represent the official views of the respective National Centers for Advancing Translational Sciences or the NIH. |
|
| Ms. Brown served as the statistical expert for this research. |
|
| Disclosure: Dr. Gadow is a shareholder in Checkmate Plus, publisher of the Child and Adolescent Symptom Inventory-4R. Dr. Arnold has received research funding from Curemark, Forest, Eli Lilly and Co., Neuropharm, Novartis, Noven, Shire, YoungLiving, NIH, and Autism Speaks; has consulted with or been on advisory boards for Arbor, Gowlings, Ironshore, Neuropharm, Novartis, Noven, Organon, Otsuka, Pfizer, Roche, Seaside Therapeutics, Sigma Tau, Shire, Tris Pharma, and Waypoint; and has received travel support from Noven. Dr. Bukstein has received royalties from Routledge Press. He has received research support, acted as a consultant and/or served on a speaker's bureau for Eli Lilly and Co., Shire, Novartis, Cephalon, and Johnson and Johnson. Dr. Findling has received research support from, acted as a consultant for, and/or served on a speaker's bureau for Alcobra, the American Academy of Child and Adolescent Psychiatry, American Physician Institute, American Psychiatric Press, AstraZeneca, Bracket, Bristol-Myers Squibb, CogCubed, Cognition Group, Coronado Biosciences, Dana Foundation, Elsevier, Forest, GlaxoSmithKline, Guilford Press, Johns Hopkins University Press, Johnson and Johnson, Jubilant Clinsys, KemPharm, Eli Lilly and Co., Lundbeck, Merck, NIH, Neurim, Novartis, Noven, Otsuka, Oxford University Press, Pfizer, Physicians Postgraduate Press, Purdue, Rhodes Pharmaceuticals, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Transcept Pharmaceuticals, Validus, and WebMD. Dr. Aman has received research contracts from, consulted with, or served on advisory boards of Biomarin Pharmaceuticals, Bristol-Myers Squibb, Cog State, Inc., Confluence Pharmaceutica, Coronado Biosciences, Forest Research, Hoffmann-La Roche, Johnson and Johnson, MedAvante Inc., Novartis, Pfizer, ProPhase LLC, and Supernus Pharmaceuticals. Drs. Butter, Farmer, Kolko, Molina, Rice, Jr., Schneider, and Mss. Brown and Buchan-Page report no biomedical financial interests or potential conflicts of interest. |
Vol 55 - N° 6
P. 469-478 - juin 2016 Retour au numéro
Article précédent
- Antipsychotic Use Trends in Youth With Autism Spectrum Disorder and/or Intellectual Disability: A Meta-Analysis
- Su Young Park, Chiara Cervesi, Britta Galling, Silvia Molteni, Frozan Walyzada, Stephanie H. Ameis, Tobias Gerhard, Mark Olfson, Christoph U. Correll
- Age of Onset, Duration, and Type of Medication Therapy for Attention-Deficit/Hyperactivity Disorder and Substance Use During Adolescence: A Multi-Cohort National Study
- Sean Esteban McCabe, Kara Dickinson, Brady T. West, Timothy E. Wilens
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?