Model System:

Burn

Reference Type:

JA

Accession No.:

J71539

Journal:

JOURNAL OF NEUROTRAUMA

Year, Volume, Issue, Page(s):

, 1, NULL, na

Publication Website:

Abstract:

Study examined the effect of amantadine on irritability in people in the post-acute period after traumatic brain injury (TBI). One hundred sixty-eight subjects with irritability 6 or more months post-TBI were enrolled in a parallel-group, randomized, double-blind, placebo-controlled trial receiving either 100 milligrams of amantadine every morning and noon or equivalent placebo for 60 days. Subjects were assessed at baseline and days 28 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 signi?cantly 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 and NPI-I Distress. CGI demonstrated greater improvement for amantadine than the placebo group. Adverse event occurrence did not differ between the two groups. This study of amantadine twice daily to reduce irritability was not positive from the observer perspective, although there are indications of improvement at day 60 from the perspective of patients with TBI and clinicians that may warrant further investigation.

Author(s):

Carrougher GJ, McMullen K, Mandell SP, Fauerbach JA, Kazis LE, Schneider JC, Holavanahalli RK, Gibran NS.

Participating Centers: