Clinical Trial Opportunity - Sites Across Canada

The CALM Study

 A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents with NeurodevelopMental 

The CALM Study is a placebo-controlled clinical trial testing sertraline (an SSRI) to reduce anxiety. Participants will be monitored with bloodwork for safety and smartwatch technology to assess changes over time.

Who can participate? 

  • 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) 

What’s involved? 

  • This study is comparing sertraline against placebo for reducing anxiety symptoms 

  • The trial is 16 weeks long 

  • There are 7 study visits 

  • Study procedures include bloodwork, smartwatch technology and questionnaires 

Potential Benefits? 

  • Sertraline may help improve anxiety symptoms in children and adolescents. 

  • This research will help other children and families with neurodevelopmental disorders. 

This study is part of the KINDtrials Network

Kids and Beyond-NeuroDevelopmental Trials Network (KINDtrials)
Réseau KINDtrials- Essais Neurodéveloppementaux pour Tous, 

is researching genes, the brain, and behaviour to find potential treatments in neurodevelopmental disorders. 

Everything You Need to Know About Joining the CALM Study

Site Locations / Contact Information:

 Toronto, ON I Kingston, ON I London, ON I Hamilton, ON I Montreal, QC I Halifax, NS I Calgary, AB I Edmonton, AB 

The CALM Study explained by

Study Sponsor:
Dr. Evdokia Anagnostou
Bloorview Research Institute

Joined by:

Dr. Kara Murias
University of Calgary

Dr. Francois Bolduc
University of Alberta

Karen Kelm
Fragile X Canada