Jay A Salpekar1, Paramjit T Joshi2, David A Axelson3, Shauna P Reinblatt4, Gayane Yenokyan5, Abanti Sanyal5, John T Walkup6, Benedetto Vitiello7, Joan L Luby8, Karen Dineen Wagner9, Nasima Nusrat10, Mark A Riddle4. 1. Kennedy Krieger Institute and Johns Hopkins University School of Medicine, Baltimore. Electronic address: Salpekar@kennedykrieger.org. 2. Children's National Medical Center and George Washington University, Washington, DC; American Academy of Child and Adolescent Psychiatry (AACAP) and with the American Board of Psychiatry and Neurology (ABPN). 3. Nationwide Children's Hospital and The Ohio State University, Columbus. 4. Johns Hopkins University School of Medicine. 5. Johns Hopkins Biostatistics Center at Johns Hopkins Bloomberg School of Public Health. 6. New York Presbyterian Hospital-Weill Cornell Medical College, New York. 7. National Institute of Mental Health (NIMH), Bethesda, MD. 8. Washington University in St. Louis. 9. University of Texas Medical Branch at Galveston. 10. Children's National Medical Center and George Washington University, Washington, DC.
Abstract
OBJECTIVE: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. METHOD: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with DSM-IV diagnoses of bipolarI disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. RESULTS:CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%; p = .03) or VAL (35.0%; p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. CONCLUSION:Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome. Clinical trial registration information-Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM); http://clinicaltrials.gov; NCT00057681.
RCT Entities:
OBJECTIVE: To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. METHOD: The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. RESULTS: CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%; p = .03) or VAL (35.0%; p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. CONCLUSION:Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome. Clinical trial registration information-Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM); http://clinicaltrials.gov; NCT00057681.
Authors: Andrew A Nierenberg; Michael J Ostacher; Joseph R Calabrese; Terence A Ketter; Lauren B Marangell; David J Miklowitz; Sachiko Miyahara; Mark S Bauer; Michael E Thase; Stephen R Wisniewski; Gary S Sachs Journal: Am J Psychiatry Date: 2006-02 Impact factor: 18.112
Authors: Gary S Sachs; Andrew A Nierenberg; Joseph R Calabrese; Lauren B Marangell; Stephen R Wisniewski; Laszlo Gyulai; Edward S Friedman; Charles L Bowden; Mark D Fossey; Michael J Ostacher; Terence A Ketter; Jayendra Patel; Peter Hauser; Daniel Rapport; James M Martinez; Michael H Allen; David J Miklowitz; Michael W Otto; Ellen B Dennehy; Michael E Thase Journal: N Engl J Med Date: 2007-03-28 Impact factor: 91.245
Authors: Ian H Stanley; Melanie A Hom; Joan L Luby; Paramjit T Joshi; Karen D Wagner; Graham J Emslie; John T Walkup; David A Axelson; Thomas E Joiner Journal: J Psychiatr Res Date: 2017-07-29 Impact factor: 4.791
Authors: Rebecca F McKnight; Saïk J G N de La Motte de Broöns de Vauvert; Edward Chesney; Ben H Amit; John Geddes; Andrea Cipriani Journal: Cochrane Database Syst Rev Date: 2019-06-01
Authors: Mary E Duffy; Anna R Gai; Megan L Rogers; Thomas E Joiner; Joan L Luby; Paramjit T Joshi; Karen D Wagner; Graham J Emslie; John T Walkup; David Axelson Journal: Bipolar Disord Date: 2019-05-09 Impact factor: 6.744