Abstract Details

Title The adaptation and utility of the Clinical Global Impression scale for studying treatment outcomes in neurodevelopmental conditions

Topic Child Neurology and Developmental Neurology

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-009

Objective

To review literature that describes the adaptation and utility of the Clinical Global Impression-Improvement (CGI-I) and Severity (CGI-S) scales and assess their suitability for studying treatment outcomes in various neurodevelopmental conditions.

Background

The CGI-I is a well-validated, clinician-rated scale commonly used to measure outcomes in central nervous system therapeutic development trials across multiple conditions. The structure of the scale supports reliable and valid adaptation to many different conditions and is especially well-suited for those with heterogeneous clinical presentations between individuals and across the lifespan.

Design/Methods We reviewed the literature on the use of the CGI-I in a wide range of neurodevelopmental conditions including autism spectrum disorder, Angelman syndrome, Fragile X syndrome, Prader-Willi syndrome, and Rett syndrome.

Results Adapted to the unique presentations across patients and over different developmental stages, CGI-I and CGI-S can be used to measure severity and change across conditions. The CGI-I allows each individual to serve as his or her own control to measure the magnitude of change from baseline CGI-S. Unlike condition-specific rating scales, the CGI-I allows the expert rater to assign weight to individual symptoms based on functional impact and clinical meaningfulness, thus avoiding presuppositions about the clinical effect of a specific investigational treatment.

Conclusions Our review describes the use of the CGI-I to measure outcome in a wide range of clinical studies, evaluating the efficacy of treatments for various neurodevelopmental conditions. This approach highlights the potential of the CGI-I to be adapted for other neurodevelopmental conditions where no condition-specific symptom rating scales are available to measure severity or change associated with an intervention.

Authors/Disclosures
PRESENTER	No disclosure on file
Anna Lee	No disclosure on file
	No disclosure on file
Alexander Kolevzon	Alexander Kolevzon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ovid Therapeutics. Alexander Kolevzon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. Alexander Kolevzon has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ovid Therapeutics. Alexander Kolevzon has received stock or an ownership interest from Ovid Therapeutics. The institution of Alexander Kolevzon has received research support from AMO Pharma. Alexander Kolevzon has received publishing royalties from a publication relating to health care.

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