Amantadine Effect on Perceptions of Irritability after Traumatic Brain Injury: Results of the Amantadine Irritability Multisite Study

Journal of Neurotrauma
Flora M HammondAmantadine Irritability Multisite Study Group

Abstract

This study examines the effect of amantadine on irritability in persons in the post-acute period after traumatic brain injury (TBI). There were 168 persons ≥6 months post-TBI with irritability who were enrolled in a parallel-group, randomized, double-blind, placebo-controlled trial receiving either amantadine 100 mg twice daily or equivalent placebo for 60 days. Subjects were assessed at baseline and days 28 (primary end-point) and 60 of treatment using observer-rated and participant-rated Neuropsychiatric Inventory (NPI-I) Most Problematic item (primary outcome), NPI Most Aberrant item, and NPI-I Distress Scores, as well as physician-rated Clinical Global Impressions (CGI) scale. Observer ratings between the two groups were not statistically significantly different at day 28 or 60; however, observers rated the majority in both groups as having improved at both intervals. Participant ratings for day 60 demonstrated improvements in both groups with greater improvement in the amantadine group on NPI-I Most Problematic (p<0.04) and NPI-I Distress (p<0.04). These results were not significant with correction for multiple comparisons. CGI demonstrated greater improvement for amantadine than the placebo group (p<0.04). Adverse event o...Continue Reading

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Citations

Dec 25, 2015·Annals of Physical and Rehabilitation Medicine·Jacques LuautéUNKNOWN SOFMER group
Jan 24, 2016·Brain Research·Saurabha BhatnagarRoss Zafonte
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Sep 12, 2017·The Journal of Head Trauma Rehabilitation·Theodore TsaousidesKristen Dams-OʼConnor
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Feb 25, 2021·Journal of Neural Transmission·Wojciech DanyszPeter Riederer

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Methods Mentioned

BETA
pharmacotherapy

Clinical Trials Mentioned

NCT00779324

Software Mentioned

SAS® Enterprise Guide

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Brain Injury & Trauma

brain injury after impact to the head is due to both immediate mechanical effects and delayed responses of neural tissues.