Psychiatry clinical trial news (quotes from article):
“Mental-health division will no longer fund research aiming to relieve symptoms without probing underlying causes.
Thomas Insel, the director of the US National Institute of Mental Health (NIMH), has had enough of shooting in the dark. He thinks that if a clinical trial of a psychiatric therapy fails, scientists should at least learn something about the brain along the way.
Now Insel is translating that belief into action: the NIMH, based in Bethesda, Maryland, has decided to stop funding clinical trials that aim merely to ease patients’ symptoms. “Future trials will follow an experimental medicine approach in which interventions serve not only as potential treatments, but as probes to generate information about the mechanisms underlying a disorder”, he wrote in a 27 February blog post announcing the move. This funding switch, which will affect grants due to be made in a few months’ time, intensifies the NIMH’s apparent shift in emphasis from abstract psychiatry to the neurobiological roots of disease.
“It’s a totally new departure for us,” says Bruce Cuthbert, a clinical psychologist and director of the institute’s adult translational-research division. Insel notes that the NIMH spent about US$100 million on clinical trials in 2013, and says that more than half of recipient projects received funding without any requirement to examine the biological processes involved in a disease. In many cases, “if you get a negative result you have no idea why, and you have to try something else at random”, Cuthbert says. “It’s an incredible waste of money.” ……. Insel maintains that the NIMH wants the trials it funds to continue to ameliorate patients’ symptoms, but to probe how their brains work at the same time. His emphasis on biological mechanisms is not unique at the US National Institutes of Health, the NIMH’s parent agency: the National Institute of Neurological Disorders and Stroke in Bethesda is increasingly aiming therapies at specific targets in the brain rather than abstract constellations of symptoms. “We’ve all been burnt badly by treating the brain as a black box,” says that agency’s deputy director, neurologist Walter Koroshetz.
The difference, Koroshetz adds, is that a great deal is already known about how neurological disorders such as Parkinson’s disease work, and that allows scientists to focus on other challenges, such as adapting drugs that work in animals to work in humans. Psychiatry has a long way to go before it will have such accurate targets. “I feel bad for them,” Koroshetz says.”
Nature 507, 288 (20 March 2014) doi:10.1038/507288a