title: Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury.
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.
authors.affiliation: Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: McAllister
authors.affiliation: Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Brigham and Women's Hospital and Harvard Medical School, Boston MA, USA.
authors.forename: Ross
authors.initials: R
authors.lastname: Zafonte
authors.affiliation: Department of Family Medicine and Public Health, Biostatistics Research Center, University of California, San Diego, CA, USA.
authors.forename: Sonia
authors.initials: S
authors.lastname: Jain
authors.affiliation: Department of Psychiatry, Neuropsychology Program, Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Laura A
authors.initials: LA
authors.lastname: Flashman
authors.affiliation: Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Mark S
authors.initials: MS
authors.lastname: George
authors.affiliation: Department of Neurosurgery, Stanford University/Lucile Packard Children's Hospital, Stanford CA, USA.
authors.forename: Gerald A
authors.initials: GA
authors.lastname: Grant
authors.affiliation: Department of Family Medicine and Public Health, Biostatistics Research Center, University of California, San Diego, CA, USA.
authors.forename: Feng
authors.initials: F
authors.lastname: He
authors.affiliation: Department of Psychiatry, University of California, San Diego, CA, USA.
authors.forename: James B
authors.initials: JB
authors.lastname: Lohr
authors.affiliation: Department of Neurosurgery, College of Medicine/Mayfield Clinic, Neuroscience Institute, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Norberto
authors.initials: N
authors.lastname: Andaluz
authors.affiliation: Department of Psychiatry, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
authors.forename: Lanier
authors.initials: L
authors.lastname: Summerall
authors.affiliation: Laureate Institute for Brain Research, Tulsa, OK, USA.
authors.forename: Martin P
authors.initials: MP
authors.lastname: Paulus
authors.affiliation: Department of Family Medicine and Public Health, Biostatistics Research Center, University of California, San Diego, CA, USA.
authors.forename: Rema
authors.initials: R
authors.lastname: Raman
authors.affiliation: Department of Psychiatry and Department of Family Medicine and Public Health, University of California, San Diego, CA, USA.
authors.forename: Murray B
authors.initials: MB
authors.lastname: Stein
mesh_terms: D000328:Adult; D000342:Affective Symptoms / Q000188:drug therapy / Q000209:etiology; D000070642:Brain Injuries, Traumatic / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D003072:Cognition Disorders / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D009483:Neuropsychological Tests; D010865:Pilot Projects; D013313:Stress Disorders, Post-Traumatic / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D005702:Galantamine; D008774:Methylphenidate