A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents with NeurodevelopMental Disorders– “CALM” Study
Summary
A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents with NeurodevelopMental Disorders– “CALM” Study
Researcher(s)
Sponsor-Investigator: Dr. Evdokia Anagnostou
Who can participate
Children and teens between 8-17 years of age with a diagnosis of a neurodevelopmental disorders (ASD, ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions) and an anxiety disorder.
What's involved
The trial will last a total of 16 weeks (4 months) and involves taking either sertraline or a placebo, as a capsule, 1 time per day for 16 weeks. You and your child will first be asked to come in for a screening session; through talking with you and completing some assessments, we will determine if your child meets eligibility criteria.
Visits will occur at participating sites: Holland Bloorview, Queen’s University, Lawson Research Institute, Alberta Children’s Hospital, University of Alberta, Ste. Justine Hospital, McMaster Children’s Hospital, or Dalhousie University. Visits will take place every 2-4 weeks while your child is taking the drug or placebo.
Participants will receive a small token of appreciation in the form of a gift card to thank them for their time.
Deadline
Interested in participating
If you are interested in participating in this study or have additional questions, please contact the site closest to you and the study staff will get back to you shortly.
Site locations are in Toronto, London, Hamilton, Kingston, Edmonton, Calgary, Montreal, and Halifax.
Holland Bloorview Kids Rehab Hospital: Please contact Karly Janisse at 416 425 6220 ext. 3297 or kjanisse@hollandbloorview.ca
Contacting us does not obligate you or your child to participate in the study.
