Atomoxetine for attention deficits following traumatic brain injury: results from a randomized controlled trial.

OBJECTIVE: To determine if atomoxetine would improve attention impairment following traumatic brain injury (TBI). SETTING: Outpatients from a free-standing, private, not-for-profit rehabilitation hospital. POPULATION: Fifty-five adult participants with a history of a single moderate-to-severe TBI, who were at least 1 year from injury and with self-reported complaints of attention difficulties. INTERVENTION: Atomoxetine, a selective norepinephrine re-uptake inhibitor with a primary indication for attention dosed at 40 mg twice a day for 2 weeks, compared to placebo. DESIGN: Randomized double-blind placebo controlled trial, with placebo run-in. MEASURES: Cognitive Drug Research (CDR), Computerized Cognitive Assessment System, Stroop Color and Word Test, Adult ADHD Self-Report Scale (ASRS-v1.1), Neurobehavioural Functioning Inventory (NFI). RESULTS: Atomoxetine was well-tolerated by the subject sample. The use of atomoxetine by individuals with reported attention difficulty following TBI did not significantly improve scores on measures of attention, the CDR Power of Attention domain or the Stroop Interference score. In addition, no significant relationship was found between atomoxetine use and self-reported symptoms of attention or depression. CONCLUSION: Atomoxetine did not significantly improve performance on measures of attention among individuals post-TBI with difficulties with attention. This study follows a trend of other pharmacological studies not demonstrating significant results among those with a history of TBI. Various possibilities are discussed, including the need for a more sophisticated system of classification of TBI.

Treatment efficacy of social communication skills training after traumatic brain injury: a randomized treatment and deferred treatment controlled trial.

OBJECTIVE: To evaluate the efficacy of a replicable group treatment program to improve social communication skills after traumatic brain injury (TBI). DESIGN: Randomized treatment and deferred treatment controlled trial, with follow-up at 3, 6, and 9 months post-treatment. SETTING: Community. PARTICIPANTS: Volunteer sample of 52 people with TBI who were at least 1 year postinjury, who received rehabilitation, and who had identified social communication deficits. INTERVENTION: Twelve weekly group sessions (1.5 h each) to improve social communication. MAIN OUTCOME MEASURES: The Profile of Functional Impairment in Communication (PFIC), Social Communication Skills Questionnaire-Adapted (SCSQ-A), Goal Attainment Scale (GAS), Craig Handicap Assessment and Reporting Technique-Short Form social integration and occupation subscales, Community Integration Questionnaire social integration and productivity subscales, and Satisfaction With Life Scale (SWLS). RESULTS: Independent samples t test analysis showed significant treatment effect compared with no treatment on 7 of 10 of the PFIC subscales (P range, .024 to <.001) and the SCSQ-A (P=.005) after the first 12 weeks of the study. After 12 weeks of treatment for all participants, repeated-measures analysis showed significant improvements from baseline on 9 of 10 PFIC subscales (P range, .01-.001), SCSQ-A (P < or = .001), GAS (P < or = .001), and SWLS (P = .011). At 6-month follow-up, scores were significantly better than baseline on 6 of 10 PFIC scales (P range, .01-.001), the SCSQ-A (P < or = .001), GAS (P < or = .001), and SWLS (P < or = .001). CONCLUSIONS: TBI subjects who received social communication skills training had improved communication skills that were maintained on follow-up. Overall life satisfaction for participants was improved.

The effect of Aricept in persons with persistent memory disorder following traumatic brain injury: a pilot study.

PRIMARY OBJECTIVE: To investigate the effectiveness of donepezil hydrochloride (Aricept) in treating persistent memory deficits in people with traumatic brain injury. RESEARCH DESIGN: Single subject ABAC design was used so that each participant could serve as their own control. METHODS AND PROCEDURES: Seven TBI survivors with persistent memory dysfunction, at least 1.5 years post-injury, underwent two 6-month trials of Aricept. The following tests were used to assess memory and cognition: Brief Visual Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test, Digit Span and Letter Number Sequence sub-test of the Wechsler Adult Intelligence Scale-III, Controlled Oral Word Association Test and Memory Functioning Questionnaire. EXPERIMENTAL INTERVENTION: During the first treatment phase, participants received 5 mg/day of Aricept for 1 month, increasing to 10 mg/day of Aricept for an additional 5 months. During the second treatment phase, participants received 5 mg/day of Aricept for the entire 6 months. MAIN OUTCOMES AND RESULTS: A repeated measures analysis of variance indicated significant improvement on immediate and delayed memory portions of the BVMT-R when taking 10 mg/day of Aricept. CONCLUSIONS: Findings contribute to the growing body of research into the use of Aricept in treating memory deficits in TBI survivors and support the need for further research.