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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06081348

Run by

Holland Bloorview Kids Rehabilitation Hospital

People needed

130

Starts

2024-09-16

Expected to finish

2027-09-01

Last updated by the study team

2026-07-27

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients 8-17 years of age, inclusive
• 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.
• 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.
• 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.
• 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)
• If already receiving interventions, must meet the following criteria:
• 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
• If already receiving stable non-pharmacological behavioural interventions, have stable participation during 3 months prior to screening, and will not electively modify ongoing interventions
• Ability to complete assessments in English

You may not qualify if…

• Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine)
• 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.
• Received more than 2 previous appropriate trials of SSRIs with no adequate response
• Pregnant females or sexually active females on inadequate contraception
• 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.
• Hypersensitivity to sertraline or any components of its formulation
• On Monoamine Oxidase Inhibitors or pimozide (as per product monograph)
• On concomitant medications known to significantly increase QT interval where this would result in unacceptable risk per Investigator judgment.
• Known congenital QT prolongation
• HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immunity disorder, major depressive episode or psychosis (as required by Health Canada)
• Unable to tolerate venipuncture
• Unable to swallow capsules
• Enrolled in another intervention study

Where it is running

• McMaster University — Hamilton, Ontario, Canada (enrolling)
• University of Alberta-Glenrose — Edmonton, Alberta, Canada (enrolling)
• Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario, Canada (enrolling)
• Alberta Children's Hospital - University of Calgary — Calgary, Alberta, Canada (enrolling)
• Queen's University — Kingston, Ontario, Canada (enrolling)
• University of Western Ontario, Lawson Health Research Institute — London, Ontario, Canada (enrolling)
• Dalhousie University - IWK Health Centre — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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