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

NCT ID: NCT06081348
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
Conditions: 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

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 130 participants (Estimated).

What is being studied

Intervention: 1-Naphthylamine
Intervention: Amines
Intervention: Chemical Actions and Uses
Intervention: Hydrocarbons
Intervention: Hydrocarbons, Aromatic
Intervention: Hydrocarbons, Cyclic
Intervention: Membrane Transport Modulators
Intervention: Molecular Mechanisms of Pharmacological Action
Intervention: Naphthalenes
Intervention: Neurotransmitter Agents
Intervention: Neurotransmitter Uptake Inhibitors
Intervention: Organic Chemicals
Intervention: Pharmacologic Actions
Intervention: Physiological Effects of Drugs
Other: Placebo
Intervention: Polycyclic Aromatic Hydrocarbons
Intervention: Polycyclic Compounds
Intervention: Selective Serotonin Reuptake Inhibitors
Intervention: Serotonin Agents
Intervention: Sertraline
Drug: Sertraline

Who may be eligible

Ages: 8 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Outpatients 8-17 years of age, inclusive 2. Females of child bearing potential who are sexually active and agree to use medically acceptable birth control throughout the study and at least one week post last dose of study drug. 3. Meet Diagnostic and Statistical Manual of Mental Disorders - DSM-5 criteria for ASD, ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions. 4. Meet DSM-5 criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Anxiety Disorder, Agoraphobia, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder, based on expert clinical interview, supported by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS; Kaufman et al., 2016). Other specified anxiety disorder is included to account for youth with impairing anxiety symptoms who may not meet criteria for one of the other anxiety disorders. 5. Have a Clinician's Global Impression-Severity for anxiety (CGI-S; Guy, 1976)) score ≥ 4 (moderately ill) (inter-rater reliability will be done prior to initiation of enrollment, using videotapes of interviews and vignettes) 6. If already receiving interventions, must meet the following criteria: 1. If receiving concomitant medications affecting behaviour, must be on a stable dose during the month prior to screening and will not electively modify ongoing medications for study duration 2. If already receiving stable non-pharmacological behavioural interventions, have stable participation during 3 months prior to screening, and will not electively modify ongoing interventions 7. Ability to complete assessments in English Exclusion Criteria: 1. Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine) 2. Previous treatment with sertraline, at an adequate dose (at least 100mg for 6 weeks, or lower dose and duration if not well-tolerated), associated with no response or significant-to-the-participant side effects. 3. Received more than 2 previous appropriate trials of SSRIs with no adequate response 4. Pregnant females or sexually active females on inadequate contraception 5. Serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger participant. In addition diabetic patients on medications for glycemic control will be excluded as sertraline may interfere with glycemic control. 6. Hypersensitivity to sertraline or any components of its formulation 7. On Monoamine Oxidase Inhibitors or pimozide (as per product monograph) 8. On concomitant medications known to significantly increase QT interval where this would result in unacceptable risk per Investigator judgment. 9. Known congenital QT prolongation 10. HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immunity disorder, major depressive episode or psychosis (as required by Health Canada) 11. Unable to tolerate venipuncture 12. Unable to swallow capsules 13. Enrolled in another intervention study

Study locations

7 study locations are listed.

Recruiting site status is explicitly provided for 7 locations; 6 are listed as Recruiting.

Countries: Canada

Alberta, Canada: 2
Nova Scotia, Canada: 1
Ontario, Canada: 4

Sample of listed locations

Alberta Children's Hospital - University of Calgary — Calgary, Alberta, Canada — Recruiting
University of Alberta-Glenrose — Edmonton, Alberta, Canada — Recruiting
McMaster University — Hamilton, Ontario, L8S4K1, Canada — Recruiting
Queen's University — Kingston, Ontario, K7M8A6, Canada — Recruiting
University of Western Ontario, Lawson Health Research Institute — London, Ontario, N6A 5W9, Canada — Recruiting
Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario, M4G 1R8, Canada — Recruiting
Dalhousie University - IWK Health Centre — Halifax, Nova Scotia, Canada — Active, not recruiting

Study details

Start date: September 16, 2024
Primary completion date: September 1, 2027
Completion date: September 1, 2027
First posted: October 13, 2023
Collaborators: Alberta Health services, Azrieli Foundation (Funder), Canadian Institutes of Health Research (Funder), Dalhousie University, Maternal, Infant, Child and Youth Research Network (MICYRN), McMaster University, Ontario Brain Institute (Funder), Queen's University, St. Justine's Hospital, The Hospital for Sick Children, Unity Health Toronto, University of Alberta, University of Toronto, Western University

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06081348
Registry last updated: July 27, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06081348 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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