A common antidepressant may tame anxiety in kids with autism and ADHD — a trial puts it to the test

NCT ID NCT06081348

Recruiting now Symptom relief Sponsor: Holland Bloorview Kids Rehabilitation Hospital Source: ClinicalTrials.gov ↗

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests whether sertraline, a widely used antidepressant, can reduce anxiety in children and teens aged 8 to 17 with neurodevelopmental disorders such as autism, ADHD, Fragile X syndrome, and Tourette syndrome. Participants receive either sertraline or a placebo for several weeks, and researchers measure changes in anxiety symptoms using parent and clinician reports. The goal is to see if this medication, already proven effective for anxiety in typically developing youth, can work for those with neurodevelopmental conditions.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: sertraline, a selective serotonin reuptake inhibitor (SSRI) also known as Zoloft
What this could lead to: If it works, this could point toward a safe, effective treatment for anxiety in children and teens with neurodevelopmental disorders.
What could go wrong: This is a small, early-stage pilot study, so results may not be definitive. Sertraline can cause side effects like nausea, sleep changes, or increased anxiety in some people.

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Conditions

The condition(s) this trial relates to.

22q11 Deletion Syndrome 22q11.2 deletion syndrome agoraphobia anxiety anxiety disorder attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder autism autism spectrum disorder DiGeorge syndrome fragile X syndrome generalized anxiety disorder neurodevelopmental disorder separation anxiety disorder social phobia tic disorder Tourette syndrome tuberous sclerosis velocardiofacial syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

22Q11 DELETION 22Q11 DELETION SYNDROME ADHD ADHD - COMBINED TYPE ADHD PREDOMINANTLY INATTENTIVE TYPE ADHD, PREDOMINANTLY HYPERACTIVE - IMPULSIVE ANXIETY ANXIETY DISORDERS AUTISM AUTISM SPECTRUM DISORDER FRAGILE X SYNDROME NEURODEVELOPMENTAL DISORDERS TIC DISORDERS TOURETTE SYNDROME TOURETTE SYNDROME IN ADOLESCENCE TOURETTE SYNDROME IN CHILDREN TUBEROUS SCLEROSIS

Contacts and locations

Locations

Alberta Children's Hospital - University of Calgary
RECRUITING

Calgary, Alberta, Canada
Dalhousie University - IWK Health Centre
ACTIVE_NOT_RECRUITING

Halifax, Nova Scotia, Canada
Holland Bloorview Kids Rehabilitation Hospital
RECRUITING

Toronto, Ontario, M4G 1R8, Canada
McMaster University
RECRUITING

Hamilton, Ontario, L8S4K1, Canada
Queen's University
RECRUITING

Kingston, Ontario, K7M8A6, Canada
University of Alberta-Glenrose
RECRUITING

Edmonton, Alberta, Canada
University of Western Ontario, Lawson Health Research Institute
RECRUITING

London, Ontario, N6A 5W9, Canada

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