Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders (NCT06081348)
A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Alberta Children's Hospital - University of Calgary — Calgary, Alberta
Age range: 8 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Alberta Children's Hospital - University of Calgary — Calgary, Alberta
- University of Alberta-Glenrose — Edmonton, Alberta
- Dalhousie University - IWK Health Centre — Halifax, Nova Scotia
- McMaster University — Hamilton, Ontario
- Queen's University — Kingston, Ontario
- University of Western Ontario, Lawson Health Research Institute — London, Ontario
- Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 425-6220
Email: fkhawaja@hollandbloorview.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neurodevelopmental Disorders
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- Reducing Missed Appointments — Baltimore, Maryland
- Patterns of Neurodevelopmental Disorders — Phoenix, Arizona
- Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders — The Woodlands, Texas
- NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment — Montreal, Quebec
Explore by condition: All Neurodevelopmental Disorders clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.