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Attention Deficit Hyperactivity Disorder (ADHD)

Rho has participated in more than a dozen ADHD research studies including 5 in the past 3 years. Our collaboration with Sponsors has included total program development; protocol development/design; study management and execution (all services); FDA interaction; Type B meeting support, attendance, and briefing package authorship and preparation; and assistance with and filing NDA submissions.

Click here to learn more about Rho's ADHD as well as other psychiatric disorder experience.

5 Lessons Learned Conducting ADHD Trials

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  • We are a leading CRO in the conduct of analog classroom studies.
  • We have very strong relationships with the 5-10 sites and clinical investigators considered to be the key opinion leaders (KOLs) in this space within the United States.
  • We have contributed to 2 NDA efforts for ADHD products and led FDA interactions. 
  • We have multiple project managers and numerous CRAs, statisticians, and data managers with recent experience conducting ADHD studies.
  • We have expertise with multiple rating scales, including:
    • Swanson, Kotin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale
    • Permanent Product Measurement of Performance (PERMP)
    • Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)
    • Conners' Parent Rating Scale (CPRS)
    • Columbia Suicide Severity Rating Scale (C-SSRS)
    • Kiddie-Sads-Present and Lifetime (K-SADS-PL)
    • Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
    • Comprehensive Global Impression Scale - Severity of Illness (CGI-S)
    • Comprehensive Global Impressions Scale-Global Improvement (CGI-I)
  • We have implemented all of the study designs and analysis methods typically used in ADHD clinical trials, including:
    • Analog classroom studies
    • Crossover designs
    • Enriched enrollment randomized withdrawal (EERW) designs
    • Mixed model repeated measures (MMRM) analyses 
    • Fixed sequence testing procedures
    • Serial gatekeeping procedures