Cymbalta Being Trialed In Kids As Young As 7
Last evening one of little header text ads appeared at the top of my gmail account, something to the effect of “Learn about MDD in kids.” MDD being major depressive disorder. So of course I clicked on the link. I was sent to a website called kidswithdepression.com. It read “Pediatric Major Depressive Disorder: Clinical Research Study” and included statements like:
“Childhood and teenage depression is often in hiding.
“Did you know that depression affects approximately 5% of children and teenagers? However, there are currently very limited treatment options for children with depression, also called Major Depressive Disorder (MDD). Research is being done that may bring alternative treatment options out into the open for children in the future.
“If your child or teenager is depressed, consider joining our research study.”
The site is a recruiting tool for a 700-person study of Cymbalta as a treatment for major depression in kids aged 7 to 17 years. The study will include a placebo arm and also use Prozac as a known comparator (interestingly, Prozac is not approved for use in 7 to 17 year olds). The study is broken out into two separate clinical trials, one of 448 kiddos and the other of 336 kids. The studies are expected to be completed in early 2012 and each runs for 36 weeks, so this is no short-term clinical trial.
The two trials come on the heels of a smaller trial of Cymbalta in 72 kids aged 7 to 17 that was completed late in 2008. I cannot find its results published anywhere. It did not have a placebo or comparator arm.
So it’s obvious that Lilly has its sights set on getting Cymbalta approved for use in kids. I cannot think of anything useful to say about that except to point out that since its introduction in 2004 Cymbalta has racked up 130 adverse events reports in the FDA’s database among kid aged 0 to 17 (so the drug hasn’t been used much off label in kids) and an astounding 14378 reports among all age groups.
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Posted in Furious Seasons