NCT05528926 RESist Against Irritability Superiority Trial
| NCT ID | NCT05528926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Irritable Mood |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-04-25 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 270 participants in total. It began in 2023-04-25 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05528926 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 15 Years, studying Irritable Mood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05528926 currently recruiting?
Yes, NCT05528926 is actively recruiting participants. Contact the research team at d-purper_ouakil@chu-montpellier.fr for enrollment information.
Where is the NCT05528926 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05528926 clinical trial?
NCT05528926 is sponsored by University Hospital, Montpellier. The trial plans to enroll 270 participants.