Spots Global Cancer Trial Database for Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
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Trial Identification
Brief Title: Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Official Title: A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Study ID: NCT06081348
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 8 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Alberta Children's Hospital - University of Calgary, Calgary, Alberta, Canada
University of Alberta-Glenrose, Edmonton, Alberta, Canada
Dalhousie University - IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster University, Hamilton, Ontario, Canada
Queen's University, Kingston, Ontario, Canada
University of Western Ontario, Lawson Health Research Institute, London, Ontario, Canada
Ste Justine Hospital - Universite de Montreal, Montréal, Quebec, Canada
Contact Details
Name: Evdokia Anagnostou
Affiliation: Holland Bloorview Kids Rehab Hospital
Role: PRINCIPAL_INVESTIGATOR
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