Citicoline, a naturally occurring compound in the human body, has been widely used abroad for the treatment of traumatic brain injury. However, citicoline has not been approved by the U.S. Food and Drug Administration for TBI treatment in the United States. The compound has been tested in preliminary clinical trials, but in most of these studies citicoline did not appear effective in treating TBI.
Scientists supported through the National Center for Medical Rehabilitation Research’s TBI and Stroke Rehabilitation Program, conducted a large-scale clinical trial that tested citicoline across a broad spectrum of TBI, from mild to severe. Researchers studied the effects of citicoline on the functional and cognitive status of over 1,200 patients with mild, moderate, or severe TBI. The investigators assessed effects both in the acute (early) treatment phase and over time (at 3 months and 6 months).
They found no significant difference, in terms of TBI patients’ functional or cognitive status, between patients given a placebo – a simulated “drug” without medical effect – and those treated with citicoline (PMID: 23168823).