Objective Measures Of ADHD Symptoms Using The Quotient(TM) ADHD System May Reduce Cost Of ADHD Drug Trials

Main Category: ADHD
Also Included In: Clinical Trials / Drug Trials
Article Date: 03 Nov 2009 - 1:00 PST

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BioBehavioral Diagnostics Company announced that its poster was presented Friday, October 30, 2009 after it was accepted via a rigorous peer-review process and included as a New Research Poster presentation at the Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in Honolulu, HI, October 27-November 1, 2009. Calvin R. Sumner, M.D., the company's Chief Medical Officer and Senior Vice President of Clinical Development, presented the study entitled "Does Placebo Response Differ Between Objective and Subjective ADHD Measures?"

Placebo response is a well-known phenomenon in ADHD clinical trials, where subjects report benefit when taking an inactive sugar pill. To achieve registration with the US FDA, drug developers must demonstrate that their product is statistically superior to placebo. Placebo response increases the cost of clinical trials by requiring more subjects or longer observation to accomplish this crucial goal. This pilot study examined the concordance of the Quotient(TM) ADHD Test, an objective assessment tool to measure hyperactivity, inattention and impulsivity, with the current standard of care, clinical ADHD rating scales (ADHD-RS). Rating scales are questionnaires that ask the subject and/or parent about the severity and frequency of ADHD symptoms.

The study indicated that implementing the Quotient(TM) ADHD System for objective measures of symptoms along with a threshold of >40% reduction in symptoms completely eliminated the placebo response. This means that it may be possible to reduce the size and cost of clinical trials for ADHD medications, which ultimately may accelerate data review by the FDA and introduction to the market.

About the Study

Thirty children aged 6 to 14 with ADHD were studied while on low dose, then medium dose ADHD medication, with the placebo course of therapy either in the beginning 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 similarity of scores while on placebo to those at baseline. While it may seem intuitively obvious that objective measures would be more sensitive to treatment effects than rating scales, objective measures of response are not often used in clinical trials. With the availability of the Quotient ADHD System, may encourage drug developers to re-evaluate the potential benefit of objective measures in differentiating placebo and drug response.

About the Quotient ADHD System

The Quotient(TM) ADHD System is FDA-cleared for objective measurement of hyperactivity, impulsivity and inattention as an aid in the assessment of ADHD. The Quotient(TM) ADHD Test takes 15 minutes for children 12 and under, or 20 minutes for adolescents and adults. The report is available within a few minutes after the patient completes the test. The clinician integrates the Quotient(TM) ADHD Test report with information from other assessment tools and the clinical evaluation to guide treatment decisions.

About BioBehavioral Diagnostics Company

BioBehavioral Diagnostics Company manufactures and markets the Quotient(TM) ADHD System, a tool that aids in the objective and accurate assessment of ADHD symptoms. We are dedicated to providing physicians, parents and patients with high-value information to guide personalized strategies and to enhance quality of life for patients with ADHD. Our vision is to provide accurate tools for the diagnosis and management of neurological and psychiatric conditions, leading to a transformation of behavioral medicine. Founded in 2006, BioBehavioral Diagnostics is a privately held company.

Source: BioBehavioral Diagnostics Company