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
