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RESist Against Irritability Superiority Trial

Study acronym: RESIST
StatusUnknown
PhaseNot applicable
Started2023-04-25
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 14, 2023 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2023-08-09
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Unknown
Start dateestimated 2023-06-01→confirmed 2023-04-25
Study sites0→1
Eligibility criteria+222 characters
Inclusion Criteria: Male and female subject between 6 and 15 years-old. InformedExpress informed consent form signedf by at least one of the parents or legal representative, and [...] s to restrict this intervention to a clinical population. A clinicianParental-rated ARI total score of 4 or above at baseline. A Clinical [...] -Severity score (CGI-S) of 4 or above (=at least moderately severeill). Persistence of irritability symptoms 6 month or above at [...] is avoids including children with transitory irritability). Ability to speak and comprehend French. No major changes instable treatment regimen (pharmacologi [...] [...]
Secondary endpoints12 to 13 entries
Exploratory efficacy endpoints and putative moderators and mediators.
2023-05-05
Study Status v1
Primary completion date2025-01-01→2026-09-01
Completion date2025-06-01→2026-09-01
Start date2022-10-01→2023-06-01
2022-09-02
Original filing
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.
Trial Details
NCT Number NCT05528926
Lead Sponsor University Hospital, Montpellier
Conditions Irritable Mood
Enrollment 270 participants
Start Date 2023-04-25
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2023-08-14