Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.

NCT Number	NCT06081348
Lead Sponsor	Holland Bloorview Kids Rehabilitation Hospital Collaborators: Azrieli Foundation (Funder), Canadian Institutes of Health Research (Funder), Ontario Brain Institute (Funder), McMaster University, Western University, Queen's University, University of Alberta, Alberta Health services, St. Justine's Hospital, Dalhousie University, Unity Health Toronto, University of Toronto, The Hospital for Sick Children, Maternal, Infant, Child and Youth Research Network (MICYRN)
Conditions	Neurodevelopmental Disorders, Autism, Autism Spectrum Disorder, Fragile X Syndrome, Tuberous Sclerosis, 22Q11 Deletion Syndrome, 22Q11 Deletion, ADHD +9 more
Enrollment	130 participants
Start Date	2024-09-16
Primary Completion	2027-09 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-27