Actively Recruiting
A Randomized Placebo-Controlled Trial of Sertraline versus Placebo for Anxiety Treatment in Children and Adolescents with Neurodevelopmental Disorders
Led by Holland Bloorview Kids Rehabilitation Hospital · Updated on 2025-07-16
130
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Holland Bloorview Kids Rehabilitation Hospital
Lead Sponsor
A
Azrieli Foundation (Funder)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating sertraline, a selective serotonin reuptake inhibitor, versus placebo for treating anxiety in children and adolescents aged 8 to 17 years with neurodevelopmental disorders (NDDs), including autism, ADHD, Fragile X syndrome, and others. This pilot study aims to estimate how much sertraline may reduce anxiety symptoms across both common and rare NDDs, and to identify the best measures for anxiety outcomes in future larger trials. Participants will be randomly assigned to receive either oral sertraline capsules at doses ranging from 25mg to 200mg or matching placebo capsules. The study uses a quadruple-blind design to compare the effects over a 16-week period. Sertraline dosing and monitoring will follow this schedule during the treatment phase. During the trial, participants will be assessed using parent-reported anxiety scales, clinician global impression scores, quality of life measures, and blood tests for serotonin levels at 16 weeks. Researchers will monitor adverse events and overall improvement in anxiety. Participants will complete evaluations and questionnaires in English or French, with safety and treatment response closely tracked throughout the study period.
CONDITIONS
Brief Title
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients aged 8 to 17 years inclusive
- Females of childbearing potential who agree to use medically acceptable birth control during the study and for one week after last dose
- Diagnosed with ASD, ADHD, Tic Disorders, Fragile X syndrome, tuberous sclerosis, or 22q11 deletions according to DSM-5
- Diagnosed with an anxiety disorder including Separation Anxiety, Social Anxiety, Agoraphobia, Generalized Anxiety, or Unspecified Anxiety based on clinical interview
- Clinician's Global Impression-Severity for anxiety score of 4 or higher (moderately ill)
- At least phrase speech ability to allow some self-report
- Stable dose of concomitant medications affecting behavior for at least one month before screening if applicable
- Stable participation in non-pharmacological behavioral interventions for at least three months before screening if applicable
- Ability to complete assessments in English or French
You will not qualify if you...
- Use of other SSRIs within four weeks before randomization (six weeks for fluoxetine)
- Previous treatment with sertraline at adequate dose with no response or significant side effects
- More than two previous adequate SSRI trials without response
- Pregnant females or sexually active females not using adequate contraception
- Serious medical conditions or diabetes on glycemic control medications
- Hypersensitivity to sertraline or its components
- Use of Monoamine Oxidase Inhibitors or pimozide
- Use of medications that significantly increase QT interval posing unacceptable risk
- Known congenital QT prolongation
- HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immunity disorder, major depressive episode, or psychosis
- Unable to tolerate venipuncture
- Unable to swallow capsules
- Currently enrolled in another intervention study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive either sertraline or placebo capsules to treat anxiety symptoms.
Regular visits for medication dispensing and assessment
Trial Site Locations
Total: 8 locations
1
Alberta Children's Hospital - University of Calgary
Calgary, Alberta, Canada
Actively Recruiting
2
University of Alberta-Glenrose
Edmonton, Alberta, Canada
Actively Recruiting
3
Dalhousie University - IWK Health Centre
Halifax, Nova Scotia, Canada
Actively Recruiting
4
McMaster University
Hamilton, Ontario, Canada, L8S4K1
Actively Recruiting
5
Queen's University
Kingston, Ontario, Canada, K7M8A6
Not Yet Recruiting
6
University of Western Ontario, Lawson Health Research Institute
London, Ontario, Canada, N6A 5W9
Actively Recruiting
7
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8
Actively Recruiting
8
Ste Justine Hospital - Universite de Montreal
Montreal, Quebec, Canada
Not Yet Recruiting
Research Team
F
Faiza Khawaja
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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