Abstract
We report findings from a 12-week randomized double-blinded placebo-controlled trial of methylphenidate or galantamine to treat emotional and cognitive complaints in individuals (n=32) with a history of PTSD, TBI, or both conditions. In this small pilot study, methylphenidate treatment was associated with clinically meaningful and statistically significant improvement compared with placebo on the primary outcome, a measure of cognitive complaints (Ruff Neurobehavioral Inventory—Postmorbid Cognitive Scale), as well as on the secondary outcomes reflecting post-concussive (Rivermead Post Concussive Symptom Questionnaire) and post-traumatic stress symptoms (Posttraumatic Stress Disorder Checklist). Treatment was well tolerated. These results suggest the need for a larger RCT to replicate and confirm these findings. Design considerations for such a trial should include the need for multiple sites to facilitate adequate recruitment and extension of the treatment and follow-up periods.
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Acknowledgements
We acknowledge Laura Burns, Leigh Chesnut, Judith Frazier, Mary Hynes, and Michael Macklin, for their contributions to this work. We are also grateful to the members of the Data Safety Monitoring Board, chaired by Gerald van Belle, PhD, for their careful oversight of the study.
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McAllister, T., Zafonte, R., Jain, S. et al. Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury. Neuropsychopharmacol 41, 1191–1198 (2016). https://doi.org/10.1038/npp.2015.282
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DOI: https://doi.org/10.1038/npp.2015.282
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