The efficacy and safety of extended-release methylphenidate following traumatic brain injury: A randomised controlled pilot study

Objective: To investigate the feasibility, safety and efficacy of extended-release methylphenidate in enhancing processing speed, complex attentional functioning and everyday attentional behaviour after traumatic brain injury. Design: Seven week randomised, placebo-controlled, double-blind, parallel pilot study. Setting: Inpatient and outpatient Acquired Brain Injury Rehabilitation Program. Participants: Eleven individuals with reduced processing speed and/or attention deficits following complicated mild to severe traumatic brain injury. Interventions: Participants were allocated using a blocked randomisation schedule to receive daily extended-release methylphenidate (Ritalin^® LA at a dose of 0.6 mg/kg) or placebo (lactose) in identical capsules. Main outcomes: Tests of processing speed and complex attention, and ratings of everyday attentional behaviour were completed at baseline, week 7 (on-drug), week 8 (off-drug) and 9 months follow-up. Vital signs and side effects were monitored from baseline to week 8. Results: Three percent (n = 11) of individuals screened participated (mean post-traumatic amnesia duration = 63.80 days, SD = 45.15). Results were analysed for six and four individuals on methylphenidate and placebo, respectively. Groups did not differ on attentional test performance or relative/therapist ratings of everyday attentional behaviour. One methylphenidate participant withdrew due to difficulty sleeping. Methylphenidate was associated with trends towards increased blood pressure and reported anxiety. Conclusion: Methylphenidate was not associated with enhanced processing speed, attentional functioning or everyday attentional behaviour after traumatic brain injury. Alternative treatments for attention deficits after traumatic brain injury should be explored given the limited feasibility of methylphenidate in this population.