Trials / Recruiting

RecruitingNCT06081348

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 130 (estimated)

Sponsor: Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
Sex: All
Age: 8 Years – 17 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	Sertraline	Oral capsule (25mg, 50mg, 100mg, 200mg)
OTHER	Placebo	Oral placebo capsule

Timeline

Start date: 2024-09-16
Primary completion: 2026-09-01
Completion: 2026-09-01
First posted: 2023-10-13
Last updated: 2025-07-16

Locations

8 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT06081348. Inclusion in this directory is not an endorsement.