RESist Against Irritability Superiority Trial

Recruiting now · Not applicable

Conditions studied: Irritable Mood

In brief

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.

Key facts

Study ID

NCT05528926

Run by

University Hospital, Montpellier

People needed

270

Starts

2023-04-25

Expected to finish

2026-09-01

Last updated by the study team

2023-08-14

Who can join

Age: 6 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subject between 6 and 15 years-old.
• Express informed consent f 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 Parental-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 ill).
• Persistence of irritability symptoms 6 month or above at baseline (this avoids including children with transitory irritability).
• stable treatment regimen (pharmacological and non-pharmacological) for 2 weeks prior to inclusion and during the trial
• RESIST-QUAL : Same inclusion criteria as above with specific informed consent form signed by the participating parent.

You may not qualify if…

• 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 or acute manic episodes.
• 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.
• absence of informed consent give by at least one of the parents or legal representatives, and oral consent of the child
• inability to speak and comprehend French
• deemed unable to comply with the trial protocol
• participation in a structured parent program during the last 6 months

Where it is running

• UH of Montpellier — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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