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

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

• Neurodevelopmental Disorders
• Autism
• Autism Spectrum Disorder
• Fragile X Syndrome
• Tuberous Sclerosis
• 22Q11 Deletion Syndrome
• 22Q11 Deletion
• ADHD
• Tic Disorders
• Tourette Syndrome
• Tourette Syndrome in Children
• Tourette Syndrome in Adolescence
• ADHD - Combined Type
• ADHD Predominantly Inattentive Type
• ADHD, Predominantly Hyperactive - Impulsive
• Anxiety
• Anxiety Disorders

Interventions

DRUG

Sertraline

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

OTHER

Placebo

Oral placebo capsule

Sponsors & Collaborators

• Azrieli Foundation (Funder)

  collaborator UNKNOWN

• Canadian Institutes of Health Research (Funder)

  collaborator UNKNOWN

• Ontario Brain Institute (Funder)

  collaborator UNKNOWN

• McMaster University

  collaborator OTHER

• Western University

  collaborator OTHER

• Queen's University

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Alberta Health services

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Maternal, Infant, Child and Youth Research Network (MICYRN)

  collaborator UNKNOWN

• Holland Bloorview Kids Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Dr. Evdokia Anagnostou · Holland Bloorview Kids Rehab Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-16

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Canada

Study Locations