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Study identifier: NCT06081348 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Neurodevelopmental Disorders · Autism · Autism Spectrum Disorder  ·  Sponsor: Holland Bloorview Kids Rehabilitation Hospital

PhasePhase 2
Planned participants130
Who can joinAll sexes, 8 Years to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Faiza Khawaja  ·  4164256220  ·  fkhawaja@hollandbloorview.ca

Always discuss trial participation with your own doctor first.

Locations (7)

Alberta Children's Hospital - University of CalgaryCalgary, Alberta, CanadaRecruiting
University of Alberta-GlenroseEdmonton, Alberta, CanadaRecruiting
Dalhousie University - IWK Health CentreHalifax, Nova Scotia, CanadaActive Not Recruiting
McMaster UniversityHamilton, Ontario, CanadaRecruiting
Queen's UniversityKingston, Ontario, CanadaRecruiting
University of Western Ontario, Lawson Health Research InstituteLondon, Ontario, CanadaRecruiting
Holland Bloorview Kids Rehabilitation HospitalToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06081348