RESist Against Irritability Superiority Trial

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders.Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats.

Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier

Criteria

Inclusion Criteria:

• Male and female subject between 6 and 15 years-old.

• Informed consent form signed by at least one of the parents or legal representative, and oral consent of the child.

• A confirmed K-SADS DSM-5 diagnosis of ADHD, ODD, CD, mood/anxiety disorder or DMDD, or a clinical diagnosis of IED. The request of a concomitant mental disorder allows to restrict this intervention to a clinical population.

• A clinician-rated ARI total score of 4 or above at baseline.

• A Clinical Global Impression-Severity score (CGI-S) of 4 or above (=at least moderately severe).

• Persistence of irritability symptoms 6 month or above at baseline (this avoids including children with transitory irritability).

• Ability to speak and comprehend French.

• No major changes in treatment regimen (pharmacological and non-pharmacological) planned during the trial.

• RESIST-QUAL : Same inclusion criteria as above with specific informed consent form signed by the participating parent.

Exclusion Criteria:

• Unavailability of parents or legal representative during the study period.

• Subjects with a DSM-5 diagnosis (clinical presentation or history) that is consistent with Schizophrenia or psychotic disorders.

• Diagnosis of Autism Spectrum Disorder (ASD) in patients who are non-verbal and with IQ lower than 70.

• Known or estimated IQ<70 or clinical diagnosis of intellectual disability.

• Subjects with severe irritability that are better accounted for by another factor, e.g.: general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use), as determined by the clinical judgment of the investigator, or related to child abuse and/or neglect.

• Change in medication 2 weeks prior to inclusion