The design of large-scale, rigorous clinical trials to evaluate mood-stabilizing treatments in children and adolescents with acute mania and bipolar disorder is the subject of a Consensus Conference convened by the American Academy of Child and Adolescent Psychiatry (AACAP).

The resulting report is published in the Spring 2003 (Volume 13, Number 1) issue of Journal of Child and Adolescent Psychopharmacology, a peer-reviewed journal. 

"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.

"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 School of Medicine, and Director, Division of Child and Adolescent Psychiatry, Bellevue Hospital Center. "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, 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.