Scientists at the Indiana University School of Medicine, Spaulding Rehabilitation Hospital/ Harvard Medical School and the University of California, San Diego, announced the results of human tests of the ADHD drug, as well as a second drug that is approved for Alzheimer’s disease treatment, in a report published online by the journal Neuropsychopharmacology.
Although the clinical trial was small, involving just 32 participants, given the results it’s “imperative” that additional trials with larger numbers of participants be organized to determine whether the results can be replicated, the authors said.
The study compared the results of treatment with methylphenidate, used to treat ADHD, and galantamine, approved to treat memory loss symptoms in Alzheimer’s disease, with placebo in patients who had been diagnosed with post-traumatic stress disorder and/or mild traumatic brain injury, and clinically significant cognitive complaints, such as memory loss and poor attention.
In the newly reported trial results, treatment with methylphenidate was associated with significant declines in post-traumatic stress disorder symptoms and post-concussion symptoms. Also noted were significant improvements in tests of attention and the ability to process information quickly, the researchers said.
The improvements in cognitive symptoms and post-traumatic stress disorder symptoms occurred early in the 12-week treatment period and were maintained throughout the treatment, effects that far exceeded those “seen for currently marketed agents used to treat PTSD,” the authors wrote.
“Emotional and cognitive complaints following PTSD and traumatic brain injury are difficult to treat, which makes these broad-ranging improvements from methylphenidate particularly interesting,” said Thomas McAllister, M.D., chair of the Department of Psychiatry at the IU School of Medicine and co-lead investigator for the study.
Co-lead investigator Ross Zafonte, D.O., chair of the Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital/Harvard Medical School, said, “The study represents an exciting opportunity for our patients and warrants replication to assure the results apply to a broad group of patients.”
In patients receiving galantamine, the drug was associated with improved episodic memory — the ability to recall details of individual events — which is consistent with the drug’s approved use for treatment of Alzheimer’s patients. However, galantamine produced no significant improvement in post-traumatic stress symptoms and post concussive symptoms.
Although traumatic brain injury and post-traumatic stress disorder are both common outcomes of traumatic events during deployment among US military personnel, the study authors note that little is known about the treatment of cognitive complaints among individuals with both post-concussion and post-traumatic stress symptoms. Moreover, studies of mild traumatic brain injury have usually excluded those with post-traumatic stress disorder and vice versa.
The study was one of several trials conducted by the Posttraumatic Stress Disorder/Traumatic Brain Injury Clinical Consortium established and funded by the U.S. Department of Defense to address cognitive, emotional and functional problems associated with traumatic brain injury and post-traumatic brain injury. That network is directed by Murray B. Stein, M.D., M.P.H., vice chair for clinical research in psychiatry at the University of California San Diego.
The study was funded by U.S. Department of Defense grant W81XWH08-2-0159.
In addition to Drs. McAllister, Zafonte and Stein, researchers contributing to the study were Sonia Jain, Rema Raman, Feng He and James B. Lohr of the University of California, San Diego, Laura A Flashman of Dartmouth University, Mark S. George of the Medical University of South Carolina, Gerald A. Grant of Stanford University, Norberto Andaluz of the University of Cincinnati, Lanier Summerall of the Ralph H. Johnson VA Medical Center, Charleston, S.C., and Martin P. Paulus of the Laureate Institute for Brain Research, Tulsa, Okla.
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