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

Anxiety Clinical Trial

Official title:
A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • 22Q11 Deletion Syndrome
  • ADHD
  • ADHD - Combined Type
  • ADHD Predominantly Inattentive Type
  • ADHD, Predominantly Hyperactive - Impulsive
  • Agoraphobia
  • Anxiety
  • Anxiety Disorders
  • Anxiety, Separation
  • Autism
  • Autism Spectrum Disorder
  • Autistic Disorder
  • DiGeorge Syndrome
  • Fragile X Syndrome
  • Generalized Anxiety
  • Generalized Anxiety Disorder
  • Neurodevelopmental Disorders
  • Phobia, Social
  • Provisional Tic Disorder
  • Separation Anxiety
  • Social Anxiety
  • Social Anxiety Disorder
  • Syndrome
  • Tic Disorders
  • Tics
  • Tourette Syndrome
  • Tourette Syndrome in Adolescence
  • Tourette Syndrome in Children
  • Tuberous Sclerosis
Clinical Trial Details
NCT number NCT06081348
Study type Interventional
Source Anagnostou, Evdokia, M.D.
Contact Karly Janisse
Phone 4164256220
Email kjanisse@hollandbloorview.ca
Status Not yet recruiting
Phase Phase 2
Start date October 2023
Completion date April 2024
View Details
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