Treatments Studies for Childhood Onset Bipolar Illness ­Are Inadequately Funded

November 5, 2010 · Posted in Political Commentary 

It was remarkable that at the Pediatric Bipolar Conference hosted by Massachusetts General Hospital (MGH) and the Ryan Licht Sang Bipolar Foundation this past March in Cambridge, Massachusetts, none of the plenary talks, although they were excellent and given by leaders in the field of child psychiatry, dealt directly with the topic of the conference–childhood-onset bipolar disorder. There were also no reports of systematic placebo-controlled clinical trials evaluating treatment approaches in any of the subsequent presentations or posters.  A number of open and uncontrolled studies examined new treatment possibilities.

It is notable that the National Institute of Mental Health (NIMH) no longer sponsors this conference, as it did for many years. Moreover, STEP-BD, an NIMH-sponsored research program on the course and treatment of adult-onset bipolar disorder, is now defunct, and the head of STEP-BD and one of the most productive researchers in bipolar illness, Andrew Nierenberg from the MGH, has been forced to search for other funding opportunities.
These developments highlight the ongoing deficient funding and study of both childhood-onset and adult-onset bipolar disorder despite the enormous public health impact, extraordinary morbidity, and early mortality from suicide and medical illnesses like cardiovascular disease that are associated with these disorders.

Over the past several years, Dr. Nierenberg has submitted multiple grants to the NIMH without receiving funding support. These included multiple studies of treatment, others designed to reveal the role of mitochondrial dysfunction in the illness (for which there is a growing amount of evidence), and studies of the offspring of the adults in the STEP-BD program, which would have provided an insight into the onset and development of pediatric bipolar disorder.

Thus, despite acknowledgements at NIMH conferences in the 1980s and 1990s that the field had failed to adequately study and fund research in adult-onset bipolar disorder for more than 30 years, and repeated calls for greater focus on treatment-related research, there has been no visible movement by NIMH in this direction in the ensuing decades. There may even be a trend in the opposite direction, i.e. away from support for treatment-related research.  This trend could also be exacerbated by a new set of NIMH initiatives that focus on the study of common symptoms (such as irritability) across multiple psychiatric illnesses with the hope that this will provide new insights into pathophysiology and genetics that will eventually lead to new treatments.

This editor and many other individuals in the field have published extensively on the need for an increase in treatment-related research for both adults and children with bipolar disorder. These publications include my article “The Perfect Storm of Childhood-Onset Bipolar Illness” published in Psychiatric Annals last year, which highlights knowledge gaps in the study and treatment of this illness, discusses some of the reasons for the sustained neglect of this topic, and proposes a variety of corrective actions. In the Psychiatric Annals article, I again called for a new national initiative to focus on the treatment of bipolar illness, particularly in children, where recognition of this disorder or its close imitators has increased explosively in the past decade and a half. The formation of a treatment outcome network for these children would help by providing much-needed treatment-related information to the field.

Not only are a million children in the US alone severely affected by bipolar illness, but there is also a paucity of studies suggesting appropriate treatments for them. Several drug companies have made progress in establishing most of the atypical antipsychotics as efficacious treatments for childhood-onset bipolar I illness in children ages 10 to 17, but data on appropriate sequencing of treatment and the development of treatment algorithms for combination treatment, which is frequently needed, are virtually nonexistent. For children under 10 years of age, many of whom have the BP NOS (not otherwise specified) subtype, almost no systematic treatment studies are available.

A New Initiative is Needed

One hopes that someone with appropriate political and scientific connections will take on the task of fostering initiatives and programs that will redress some of the deficits in the research and treatment portfolio on bipolar illness. Scores of recent articles by investigators in the field have called for such an increase in research in childhood onset bipolar illness, but to no avail. Thus, it appears that some outsider, some advocacy group, or someone with political clout must take the lead in order to begin to ameliorate this shortcoming.

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