TY - JOUR
T1 - Methodological issues and controversies in clinical trials with child and adolescent patients with bipolar disorder
T2 - Report of a consensus conference
AU - Carlson, Gabrielle A.
AU - Hellander, Martha
AU - Kowatch, Robert
AU - Kusumakar, Vivek
AU - Laughren, Thomas
AU - Leibenluft, Ellen
AU - McCracken, James
AU - Nottelmann, Editha
AU - Pine, Daniel
AU - Sachs, Gary
AU - Shaffer, David
AU - Jensen, Peter S.
AU - Simar, Renee
AU - Strober, Michael
AU - Weller, Elizabeth B.
AU - Wozniak, Janet
AU - Youngstrom, Eric A.
AU - Findling, Robert L.
AU - Meyer, Roger E.
AU - Calabrese, Joseph
AU - DelBello, Melissa P.
AU - Emslie, Graham
AU - Flynn, Laurie
AU - Goodwin, Frederick
PY - 2003
Y1 - 2003
N2 - Objective: To achieve consensus among researchers, pharmaceutical industry representatives, federal regulatory agency staff, and family advocates on a template for clinical trials of acute mania/bipolar disorder in children and adolescents. Method: The American Academy of Child and Adolescent Psychiatry, in collaboration with Best Practice, convened a group of experts from the key stakeholder communities (including adult psychiatrists with expertise in bipolar disorder) and assigned them to workgroups to examine core methodological issues surrounding the design of clinical trials and, ultimately, to generate a consensus statement encompassing: (1) inclusion/exclusion criteria, (2) investigator training needs and site selection, (3) assessment and outcome measures, (4) protocol design and ethical issues unique to trials involving children/adolescents, and (5) regulatory agency perspectives on these deliberations. Results: Conference participants reached agreement on 18 broad methodological questions. Key points of consensus were to assign priority to placebo-controlled studies of acute manic episodes in children and adolescents aged 10-17 years, who may or may not be hospitalized, and who may or may not suffer from common comorbid psychiatric disorders; to require that specialist diagnostic "gatekeepers" screen youths' eligibility to participate in trials; to monitor interviewer and rater competency over the course of the trial using agreed upon standards; and to develop new tools for assessment, including scales to measure aggression/rage and cognitive function, while using the best available instruments (e.g., Young Mania Rating Scale) in the interim. Conclusions: Methodologically rigorous, large-scale clinical trials of treatment of acute mania are urgently needed to provide information regarding the safety and efficacy, in youth, of diverse agents with potential mood-stabilizing properties.
AB - Objective: To achieve consensus among researchers, pharmaceutical industry representatives, federal regulatory agency staff, and family advocates on a template for clinical trials of acute mania/bipolar disorder in children and adolescents. Method: The American Academy of Child and Adolescent Psychiatry, in collaboration with Best Practice, convened a group of experts from the key stakeholder communities (including adult psychiatrists with expertise in bipolar disorder) and assigned them to workgroups to examine core methodological issues surrounding the design of clinical trials and, ultimately, to generate a consensus statement encompassing: (1) inclusion/exclusion criteria, (2) investigator training needs and site selection, (3) assessment and outcome measures, (4) protocol design and ethical issues unique to trials involving children/adolescents, and (5) regulatory agency perspectives on these deliberations. Results: Conference participants reached agreement on 18 broad methodological questions. Key points of consensus were to assign priority to placebo-controlled studies of acute manic episodes in children and adolescents aged 10-17 years, who may or may not be hospitalized, and who may or may not suffer from common comorbid psychiatric disorders; to require that specialist diagnostic "gatekeepers" screen youths' eligibility to participate in trials; to monitor interviewer and rater competency over the course of the trial using agreed upon standards; and to develop new tools for assessment, including scales to measure aggression/rage and cognitive function, while using the best available instruments (e.g., Young Mania Rating Scale) in the interim. Conclusions: Methodologically rigorous, large-scale clinical trials of treatment of acute mania are urgently needed to provide information regarding the safety and efficacy, in youth, of diverse agents with potential mood-stabilizing properties.
KW - Assessment
KW - Bipolar spectrum
KW - Bipolar-not otherwise specified (BP-NOS)
KW - Clinical trials
KW - Ethics
KW - Mania
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U2 - 10.1089/104454603321666162
DO - 10.1089/104454603321666162
M3 - Article
C2 - 12804123
AN - SCOPUS:0038556728
SN - 1044-5463
VL - 13
SP - 13
EP - 27
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
IS - 1
ER -