Objective Measures of ADHD Symptoms Using the Quotient(TM) ADHD System May Reduce Cost of ADHD D...(g or at the end of the study. Response t...)

Date:11/2/2009

g or at the end of the study. Response to placebo was classified using three thresholds for reduction from baseline to the placebo visit on the ADHD-RS Total Score or Quotient(TM) Global Score -- any improvement, greater than 25% improvement, or greater than 40% improvement. The latter thresholds have been used previously in ADHD research and found to correlate with moderate and robust improvement of symptoms, based on the most rigorous measures used in ADHD trials.

Placebo response rates were numerically lower when response was determined using the Quotient(TM) ADHD System rather than rating scales and when the most stringent response threshold was used (i.e., >40% improvement). Intuitively, one would expect low response results because there should be no response at all when an inactive placebo is in use. Timing of administration of placebo did not affect the number of subjects meeting response thresholds for the Quotient(TM) Global score.

Overall, baseline and placebo visit scores were more strongly correlated with response determined using the Quotient(TM) ADHD Test than ratings on the ADHD-RS. Lin's concordance correlation coefficient for the Quotient(TM) Global score was 0.78, compared with 0.38 for the ADHD-RS Total score. There was stronger agreement between the baseline and Week 3 placebo scores than the agreement between baseline and Week 1 placebo scores for both measures. Concordance coefficients for baseline and Week 3 placebo were 0.84 for Quotient(TM) Global Score and 0.45 for the ADHD-RS Total score. When comparing the baseline to week 1 placebo scores, the concordance coefficients were 0.75 for Quotient(TM) Global Score and 0.27 for the ADHD-RS Total score.

The results of this study suggest that the placebo response rate is minimized by using the Quotient(TM) ADHD System and the >40% improvement response threshold. In addition, the timing of placebo exposure seems to affect the rate of response and the simila
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