Innovations in Pediatric Depression Assessment: The Electronic CDRS-R

What is the Children’s Depression Rating Scale – Revised (CDRS-R)?

The Children’s Depression Rating Scale – Revised (CDRS-R) is a semi-structured, clinician-rated interview that measures the presence and severity of depressive symptoms. It is used as the primary efficacy scale in clinical trials for pediatric depression. 

Similar to other measures used in pediatric studies, the scale requires separate interviews with the child and the parent/caregiver. The clinician then makes “best estimate” scores, which are the final scores based on the information gathered from both interviews. 

Although it is the FDA gold standard for pediatric depression trials, there are some factors to consider when including it in a study such as:

• Limited specialized child psychiatric research infrastructure - Experienced child psychiatric research sites are few and far between, especially outside of the U.S.
• Variability in administration - Overall, there is varied experience with the CDRS-R, which results in variable administration

Digital Innovation with Signant’s Electronic CDRS-R (eCDRS-R)

In order to address these considerations, Signant has developed an electronic CDRS-R (eCDRS-R) with integrated quality control mechanisms designed to increase data reliability and ensure that the scale is administered and scored thoroughly, accurately, and in accord with scale conventions. 

Signant's eCDRS-R:

• Guides raters through required order of assessment
• Ensures thorough coverage of all symptom domains
• Improves administration via embedded training and guidance
• Pulls through parent and child responses depending on order of interview (for ages 12 and under, interview parent first; for ages 13 and older, interview adolescent first)
• Displays scores the rater has provided for the parent and child interviews to help facilitate the “best estimate” score decision
• Can be used to help assess rater quality using programmed algorithms in background (not shown to rater)
• Includes translations for international studies

International Acceptance and Feasibility

Signant's eCDRS-R has been used successfully in multiple national and international trials. It has been acclaimed repeatedly by PIs and sponsors. It is an important tool for helping to improve data quality in this critically important area of great patient need.

Conclusion: Advancing the Science of Pediatric Depression Assessment

Pediatric depression represents a significant public health concern with substantial unmet treatment needs. Rigorous assessment methodology is essential for identifying effective interventions. Signant’s eCDRS-R represents an evidence-based solution that addresses the challenges inherent in multi-site pediatric depression trials while maintaining the psychometric integrity of this gold-standard measure.

For sponsors committed to methodological excellence in pediatric depression research, the eCDRS-R provides a scientifically validated platform to enhance assessment standardization, improve data quality, and ultimately accelerate the identification of effective treatments for this vulnerable population. It is an important tool for helping to improve data quality in this critically important area of great patient need.

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About the authors

Samantha Silverman holds Master's degrees in Health Psychology and Public Health. She joined Signant Health in 2013 and serves as both a Senior Clinical Scientist and eCOA Clinical Scientist in the Digital Health Science Department. In her dual role, she works across various indications and acts as a liaison between clinical and technical teams for studies using Signant's electronic clinician ratings platform, Rater Station®.

Elizabeth is a Program Manager in eCOA Clinical Science at Signant Health, with 14 years of experience in clinical trials. She holds a Master's in Forensic Psychology and has extensive clinical experience across various settings. At Signant Health since 2011, Elizabeth has worked as a Clinical Lead, focusing on rater training and monitoring, particularly with the Rater Station® platform. Her expertise spans pediatric, adult, and geriatric CNS and neurological indications.

Margot is a Masters-level Registered Nurse with a diverse clinical background. Her extensive nursing experience covers various medical diagnoses and settings. She has prior experience in clinical trial work at research sites and as a Clinical Research Associate for a CRO. For the past 16 years with Signant Health, she focuses on pediatric and adult CNS clinical studies, with recent emphasis on pediatric rare diseases.

Dr. Busner has over 35 years of experience as an academic psychiatric researcher, serving as Principal Investigator for 49 clinical trials and Sub-Investigator for 35 more. She has authored or co-authored over 140 peer-reviewed articles and presentations. Before joining Signant Health, she directed psychiatric clinical trials at two major medical schools and served on University IRBs for 20 years. Currently an Affiliate Associate Professor of Psychiatry at Virginia Commonwealth University, Dr. Busner leads studies at Signant on pediatric, rare, and psychiatric disorders, and has trained thousands of clinical trial investigators worldwide.