Drugs for treating depression have been around for years now, mostly working in similar ways by blocking certain receptors in the brain. So when San Diego-based BrainCells Inc. proposed a clinical trial with a new way of combining a generic anti-anxiety drug with a common dietary supplement that affects people’s sleeping rhythms, this didn’t exactly set the medical field on fire.
“If you had asked psychiatrists beforehand if buspirone and melatonin would work together as a depression drug, they’d say absolutely not,” says Dr. Maurizio Fava, the vice chair of the department of psychiatry at Massachusetts General Hospital.
This combination, which BrainCells has put together under the code name BCI-952, is now getting a second look by those psychiatrists. This drug combination showed promise in a clinical trial of 142 patients diagnosed with major depression, according to results presented by Fava last week at a mental health medical meeting. The drug showed “comparable” effectiveness to what researchers have seen with the standard depression medicines, known as selective serotonin reuptake inhibitors (SSRIs), Fava says.
This result is far from the conclusive evidence the FDA wants to see before it will approve a drug, but it’s tantalizing. An estimated 20 million people in the U.S. suffer from depression—and the existing drugs don’t work for everybody and can cause sexual side effects and weight gain. The BrainCells combination didn’t show those side effects, and it is thought to have a completely different way of working, by stimulating the growth of new neurons in the brain.
“Is it possible that this combination may work better than standard anti-depressants? I’d say, yes, it’s possible,” Fava says.
That said, it’s still quite early in the development of BCI-952, when a lot of things are still possible, not all of them good. Here’s what we know. The BrainCells trial enrolled 142 patients, and randomly assigned about half to get the company’s combination of buspirone and melatonin, while the rest … Next Page »
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