Improve Data Reliability from MADRS and HAM-D Assessments in Clinical Trials: Scientific and Operational Recommendations

For clinical trials in mood disorders, two of the most widely leveraged and long-standing assessments of depression severity are the Montgomery–Åsberg depression rating scale (MADRS) and the Hamilton depression rating scale (HDRS or HAM-D). Both are complex clinician-administered assessments. When used in clinical trials, it is always recommended that raters follow the associated structured clinical interview guides for each scale — structured interview guide for MADRS (SIGMA) and structured interview guide for HDRS (SIGH-D). If not administered properly, the nuances in these scales can lead to data issues around inter-rater reliability and cause potential risks in the validity of study data such as in response to efficacy and safety questions.

In this webinar, three clinical trial experts with years of experience supporting and utilizing these psychiatric measures will share both scientific and operational considerations to achieve high-quality data collection from MADRS and HAM-D administrations.

Join this webinar and learn from their experiences about what makes an excellent rater for these scales, how to take a targeted and tailored rater training approach based on common administration errors, and ways to catch rater drift before it becomes problematic. The presenters will also describe an approach called central rating that can increase quality and consistency while reducing site burden and heightening diversity.

Speakers

Kim Baldwin, Associate Director, Clinician Network, Cogstate

Kim Baldwin is a seasoned clinical research professional known for her extensive expertise in clinical assessment, central rating, quality oversight, training and trial operations. She has a versatile therapeutic background spanning many populations and has worked in individual, family, group and community mental health settings.

Currently, Kim is the Associate Director of the Clinician Network at Cogstate — encompassing 180+ clinical and scientific experts around the world. Her career journey also includes roles as a Clinical Scientist at MedAvante-ProPhase and Clinician at Worldwide Clinical Trials. She has leveraged her skills to contribute significantly to clinical support and training.

Kim has an MA in Clinical Psychology from Pepperdine University and a BA in Psychology from The University of Texas in Austin.

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Felice Ockun, Senior Manager, Clinician Network, Clinical Trials, Cogstate

Felice Ockun is a seasoned mental healthcare professional with more than 25 years of experience in the mental healthcare industry, specializing in global clinical CNS trials, psychiatric diagnosis, rater training, quality oversight and clinical data analytics. Felice’s diverse background spans management roles in clinical trials, inpatient/outpatient mental healthcare and emergency mental healthcare settings.

Currently, she is the Senior Manager for Cogstate’s Clinician Network — encompassing 180+ clinical and scientific experts around the world. Previously Felice has worked for MedAvante, Prophase, Bracket Global, MedavanteProPhase (WCG), the New York State Psychiatric Institute and Princeton House Behavioral Health. She has served as an expert Rater, internal and external Trainer and Clinical Specialist in psychiatric and neuropsychological trials and has contributed to numerous drugs obtaining FDA approval.

Felice received an MS in Clinical Psychology from LIU’s Clinical Psychology doctoral program, specializing in severe and persistent mental illness and an MS in Clinical Social Work from Columbia University. She also holds a BA in Psychology and Sociology from Emory University.

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Janelle Eloi, PhD, Principal Clinical Scientist, Cogstate; Licensed Neuropsychologist

Janelle Eloi is a licensed neuropsychologist with expertise in neurological and psychiatric disorders. Janelle is dedicated to rigorous research and clinical excellence to help advance clinical neuropsychology. Currently, she serves as a Principal Clinical Scientist at Cogstate. She has clinical trial experience in Alzheimer’s disease and other CNS conditions as well as expertise in clinical trial scales such as the ADAD-Cog, PACC-5, CDR, RBANS, SCID, MADRS, HAM-D etc.

Her prior work and training experience include Staten Island University Hospital — Northwell Health and Emerson Hospital where she administered neuropsychological evaluations to individuals with CNS conditions, conducted research, participated in clinical trials and continues to engage in research pertaining to cognitive changes in individuals who have had COVID-19.

Janelle holds a PhD and an MS in Clinical Psychology (with a concentration in neuropsychology) from William James College and a post-baccalaureate certificate in psychology from Tufts University. She completed a research and clinical fellowship at Dartmouth-Hitchcock Medical Center, conducting comprehensive assessments for diverse populations and extensive research on the psychometric properties of cognitive tests.

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