Controversies Related to Drug Testing in Children and Teens With Bipolar Disorder Are Topic of Concensus Conference Report Published in Journal of Child and Adolescent Psychopharmacology.Business Editors LARCHMONT, N.Y.--(BUSINESS WIRE)--Jan. 24, 2003 The design of large-scale, rigorous clinical trials to evaluate mood-stabilizing treatments in children and adolescents with acute mania and bipolar disorder bipolar disorder, formerly manic-depressive disorder or manic-depression, severe mental disorder involving manic episodes that are usually accompanied by episodes of depression. is the subject of a Consensus Conference convened by the American Academy of Child and Adolescent Psychiatry A branch of psychiatry that specialises in work with children, teenagers, and their families. History An important antecedent to the specialty of child psychiatry was the social recognition of childhood as a special phase of life with its own developmental stages, starting with (AACAP AACAP American Academy of Child and Adolescent Psychiatry AACAP ATSIC/Army Community Assistance Program AACAP Area Agency on Aging of the Capital Area (Texas) ). The resulting report is published in the Spring 2003 (Volume 13, Number 1) issue of Journal of Child and Adolescent Psychopharmacology psychopharmacology (sī'kōfär'məkŏl`əjē), in its broadest sense, the study of all pharmacological agents that affect mental and emotional functions. , a peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. published by Mary Ann Liebert, Inc. (www.liebertpub.com). The report, entitled "Methodological Issues and Controversies in Clinical Trials with Child and Adolescent Patients with Bipolar Disorder" may be viewed free online at www.liebertpub.com/cap. "The Research Forum Group of 60 experts in bipolar disorder and psychopharmacology has moved the field forward by addressing many of the obstacles to developing research on effective treatments for young people with this serious condition," says Gabrielle A. Carson, M.D., Professor of Psychiatry and Pediatrics at Stony Brook University The State University of New York at Stony Brook (SUNYSB), also known as Stony Brook University (SBU) is a public research university located in Stony Brook, New York (on the north side of Long Island, about 55 miles east of Manhattan, New York). . "This is a blueprint for the scientific evaluation of psychotropic medications in children and adolescents diagnosed with bipolar disorder, and it provides a model for future productive cooperation among child psychopharmacologists, their patients and their families, academic medical centers, the pharmaceutical industry, and regulatory agencies," says journal Editor Harold S. Koplewicz, M.D., Director, Child Study Center, and Vice Chairman, Department of Psychiatry, New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the School of Medicine, and Director, Division of Child and Adolescent Psychiatry, Bellevue Hospital Center Bellevue Hospital Center, founded in 1736, is the oldest public hospital in the United States. It is located in New York City and has been the site of countless milestones in the history of medicine. . "It will be a force in moving our field forward." Recognizing the urgent need to resolve controversies involving the methods used to test treatments for child and adolescent bipolar disorder, the AACAP gathered together a group of experts, including psychiatrists and pharmaceutical industry representatives, to devise appropriate methods for designing clinical trials. The issues evaluated included inclusion and exclusion criteria exclusion criteria AIDS Donor exclusion criteria, see there , investigator training, site selection, assessment and outcome measures, protocol design, ethical issues related to drug testing in children and adolescents, and regulatory perspectives. Conferees reached agreement on 18 key methodological questions. They assigned priority to placebo-controlled studies of acute manic episodes in youths aged 10 to 17 years. Another point of consensus was the need for specialist diagnostic "gatekeepers" to screen youths for eligibility to participate in trials. The experts also agreed on the need for new assessment tools, including measures of aggression/rage and cognitive function, and the need to monitor interviewer and rater competency throughout a trial. Journal of Child and Adolescent Psychopharmacology is an authoritative peer-reviewed journal published quarterly in print and online. The journal is dedicated to child and adolescent psychiatry and behavioral pediatrics, covering clinical and biological aspects of child and adolescent psychopharmacology and developmental neurobiology Neurobiology Study of the development and function of the nervous system, with emphasis on how nerve cells generate and control behavior. The major goal of neurobiology is to explain at the molecular level how nerve cells differentiate and develop their . A complete table of contents and free sample issue may be viewed online at www.liebertpub.com/CAP. Mary Ann Liebert, Inc., is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including CyberPsychology & Behavior. Its biotechnology trade magazine, Genetic Engineering News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 60 journals, books, and newsletters is available at www.liebertpub.com. |
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