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

• Status: Not yet recruiting
• Trial end date: 2024-04-01

Summary

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.

• Phase: Phase 2

Details

• Lead Sponsor: Anagnostou, Evdokia, M.D.
• Collaborators: Alberta Health services; Azrieli Foundation; Canadian Institutes of Health Research (CIHR); Dalhousie University; Holland Bloorview Kids Rehabilitation Hospital; McMaster University; Ontario Brain Institute; Queen's University; St. Justine's Hospital; The Hospital for Sick Children; Unity Health Toronto; University of Alberta; University of Toronto; Western University
• Treatments: Selective Serotonin Reuptake Inhibitors; Serotonin; Sertraline