Ethical issues in research and innovative therapy in children with mood disorders.

Research involving children with mood disorders should generally offer a reasonable prospect of benefit to those involved, unless the risks are minimal. While federal regulations require a prospect of direct benefit, from an ethical perspective indirect benefits, such as the advantages of being in a clinical trial, are relevant. Standard care should not be presumed to be preferable to treatment in the context of a clinical trial, particularly if it has not been evaluated in well designed studies involving groups comparable to the patient. Similarly, active treatments in a controlled trial should not be presumed to be preferable to placebos, particularly in studies involving mood disorders where the placebo effect is more likely to be substantial. Innovative therapy-using approved drugs for unapproved purposes-may be more problematic than research, on theoretical and empirical grounds. Studies with no prospect of direct benefit and more than minimal risk are problematic when the patient is incompetent to provide meaningful consent. Whether or not a controlled trial involving children with mood disorders can be ethically justified depends on several factors, including the validity of standard treatment, the seriousness of the disorder, the likelihood of adverse consequences if treatment is delayed, the burden of the proposed intervention, and value judgments by parents, working collaboratively with a caring physician.