@entity7776 Effect on Perceptions of Irritability after Traumatic Brain Injury: Results of the XXXX Irritability Multisite Study.

@entity1 @entity7776
This study examines the effect of @entity7776 on irritability in @entity1 in the post-acute period after traumatic brain injury (TBI). There were 168 @entity1 >= 6 months post-TBI with irritability who were enrolled in a parallel-group, randomized, double-blind, placebo-controlled trial receiving either @entity7776 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 @entity1 -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. @entity1 ratings for day 60 demonstrated improvements in both groups with greater improvement in the @entity7776 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 @entity7776 than the placebo group (p<0.04). Adverse event occurrence did not differ between the two groups. While observers in both groups reported large improvements, significant group differences were not found for the primary outcome (observer ratings) at either day 28 or 60. This large placebo or nonspecific effect may have masked detection of a treatment effect. The result of this study of @entity7776 100   mg every morning and noon to reduce irritability was not positive from the observer perspective, although there are indications of improvement at day 60 from the perspective of @entity1 with TBI and clinicians that may warrant further investigation.
