# The “CALM” Study

A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents with NeurodevelopMental Disorders: The “CALM” Study

Participate in the CALM study testing a medication called sertraline to see if it reduces anxiety in youth with neurodevelopmental disorders.

You can participate if you are:

Children and teens between 8 and 17 years old

Diagnosed with autism spectrum disorder (ASD), ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions

Meet criteria for an anxiety disorder

Able to tolerate venipuncture (bloodwork)

Study involves:

comparing sertraline against placebo for reducing anxiety symptoms

bloodwork

smart watch technology

questionnaires

Anxiety symptoms monitored over time.

Anxiety in children with autism spectrum disorder (ASD), ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions

Date posted: June 3, 2026
Sponsor: This study is enrolling at multiple institutions in Canada. To find out more information, please contact the study team

Investigators:

Dr. Evdokia Anagnostou, MD
Pediatric Neurologist, Holland Bloorview

Dr. Francois Bolduc, MD, PhD, FRCPC, Associate Professor Pediatric Neurology; Adjunct Associate Professor Medical Genetics, University of Alberta