RecruitingPhase 2NCT06081348

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

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


Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Enrollment

130 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether sertraline (a common antidepressant/anti-anxiety medication) can reduce anxiety symptoms in children and teenagers who have neurodevelopmental disorders such as autism spectrum disorder (ASD), ADHD, Fragile X syndrome, or tic disorders. **You may be eligible if...** - You are between 8 and 17 years old - You have been diagnosed with ASD, ADHD, tic disorders, Fragile X, tuberous sclerosis, or 22q11 deletion syndrome - You also have a significant anxiety disorder (such as separation anxiety, social anxiety, or generalized anxiety) - Your anxiety is rated as at least moderately severe by a clinician - Your current medications have been stable for at least one month **You may NOT be eligible if...** - You are currently taking another SSRI antidepressant - You have previously tried sertraline without benefit or with significant side effects - You have tried and failed more than two SSRIs - You are pregnant or sexually active without adequate contraception - You have HIV, hepatitis, hemophilia, or a serious medical condition that may interact with sertraline - You are taking MAO inhibitors or pimozide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSertraline

Oral capsule (25mg, 50mg, 100mg, 200mg)

OTHERPlacebo

Oral placebo capsule


Locations(8)

Alberta Children's Hospital - University of Calgary

Calgary, Alberta, Canada

University of Alberta-Glenrose

Edmonton, Alberta, Canada

Dalhousie University - IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster University

Hamilton, Ontario, Canada

Queen's University

Kingston, Ontario, Canada

University of Western Ontario, Lawson Health Research Institute

London, Ontario, Canada

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Ste Justine Hospital - Universite de Montreal

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06081348


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