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Genetic and Clinical Correlates of Disruptive Behavior Disorder With and Without Callous-Unemotional Traits

Study acronym: GENCU 2025
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: 2 to 4
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 2 to 4
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Disruptive Behavior Disorders (DBD), such as Conduct Disorder (CD) and Oppositional Defiant Disorder (ODD), affect children and adolescents in different ways. Research has shown that some individuals with DBD also display callous-unemotional (CU) traits, including a lack of guilt, uncaring behavior, and shallow emotions. This subgroup tends to have more severe symptoms and a higher risk of negative outcomes. Previous studies suggest that genetic factors may play a role in the development of DBD with CU traits. For example, specific variations of the MAOA gene have been linked to difficulties in recognizing and processing emotions such as sadness and fear, which are often impaired in individuals with CU traits. This study aims to explore how broader genetic profiles may affect DBD and CU traits. In the already enrolled sample, we will explore correlations between the collected clinical data and a larger set of genetic variants. The goal is to improve knowledge about the genetic factors that contribute to differences in behavior, which may help inform strategies to identify risk and resilience in individuals with disruptive behavioral traits.
Trial Details
NCT Number NCT07322055
Lead Sponsor IRCCS Fondazione Stella Maris
Collaborators: University of Pisa
Conditions
(from sponsor)		 Conduct Disorder, Oppositional Defiant Disorder, Callous Unemotional Traits
Related terms Conduct Disorder, Oppositional Defiant Disorder
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov