Actively Recruiting
Sertraline vs. Placebo in the Treatment of Anxiety 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
102 weeks
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
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
Official 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 who are sexually active must agree to use medically acceptable birth control during the study and for at least one week after the last dose
- Diagnosis meeting DSM-5 criteria for autism spectrum disorder, ADHD, tic disorders, or genetic diagnosis of Fragile X syndrome, tuberous sclerosis, or 22q11 deletions
- Diagnosis meeting DSM-5 criteria for separation anxiety disorder, social anxiety disorder, agoraphobia, generalized anxiety disorder, or unspecified anxiety disorder based on expert clinical interview and supported by KSADS
- Clinician's Global Impression-Severity score for anxiety of 4 or higher (moderately ill)
- At least phrase speech to allow for some self-report; no IQ cutoff
- If on behavioral or medication interventions, doses or participation must be stable for at least 1 month (medications) or 3 months (behavioral interventions) before screening and unchanged during study
- Ability to complete assessments in English or French
You will not qualify if you...
- Receiving other SSRIs within 4 weeks of randomization (6 weeks for fluoxetine)
- Previous treatment with sertraline at an adequate dose and duration with no response or significant side effects
- More than 2 previous adequate SSRI trials with no adequate response
- Pregnant or sexually active females not using adequate contraception
- Serious medical conditions interfering with study or safety, including diabetes on glycemic control medications
- Hypersensitivity to sertraline or its components
- Taking Monoamine Oxidase Inhibitors or pimozide
- Using medications that significantly increase QT interval posing unacceptable risk
- Known congenital QT prolongation
- HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immune disorders, major depressive episode, or psychosis
- Unable to tolerate blood draws
- Unable to swallow capsules
- Enrolled in another intervention study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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