A Phase 2 interventional study of Sertraline and Placebo in Neurodevelopmental Disorders, Autism and Autism Spectrum Disorder, sponsored by Holland Bloorview Kids Rehabilitation Hospital. Recruiting at 7 sites in Canada. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Holland Bloorview Kids Rehabilitation Hospital · Phase 2, Interventional, and Treatment
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.
If already receiving interventions, must meet the following criteria:
Exclusion Criteria:
Drug: Sertraline
Other: Placebo
Oral capsule (25mg, 50mg, 100mg, 200mg)
Also known as: Sertraline Hydrochloride, Zoloft, Serotonin Reuptake Inhibitor
Oral placebo capsule
The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version
The SCARED is a 41-item measure of anxiety symptoms, with both child and parent versions. The parent version will be used as a primary outcome measure. The minimum overall score is 0 while the maximum overall score is 82. A score greater than or equal to 25 may indicate the presence of an Anxiety Disorder. Higher scores indicate a higher instance of anxiety symptoms while a lower score indicates a lower instance of anxiety symptoms.
Time frame: 16 weeks
Clinical Global Impressions - Improvement Scale - Global (CGI-I)
The CGI-I is a clinician reported scale which will be used to examine the effect of sertraline vs. placebo on measures of global function. The CGI-Improvement Scale employs a seven point (1 = very much improved to 7 = very much worse) to determine the participant's improvement in response to treatment.
Time frame: 16 weeks
Adverse events
Adverse events as elicited by the SMURF.
Time frame: 16 weeks
Pediatric Quality of Life Inventory (PedsQL)
The PedsQL will be used to examine the effect of sertraline vs. placebo on measures of quality of life. The PedsQL is measuring health-related quality of life (HRQOL) in 2- to 18-year-olds. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent-proxy report scales that have been used extensively as an outcome measure, including in ASD. We will use the parent-proxy report scale, and optionally, age-appropriate child self-report scale. Each item is is rated between a 0 (Never a problem) to 4 (Almost always a problem).
Time frame: 16 weeks
Whole blood serotonin (5-HT) assessment
A whole blood serotonin assessment will be completed to examine the effect of sertraline vs. placebo on biomarkers of serotonin. 3mL of blood will be drawn at screening and week 16 visits for the purpose of this assessment. High performance liquid chromatography will be performed using fluorometric detection of 5-HT, tryptophan (TRP), and 5-hydroxyindole acetic acid (5-HIAA), using N-methylserotonin as an internal standard. Using this method, 5-HT intra- and inter- assay coefficients of variation are reliably less than 5% and 10%, respectively.
Time frame: 16 weeks
Clinical Global Impressions- Improvement Scale (CGI-I) focused on anxiety
The CGI-I is a clinician reported scale which will be used to examine the effect of sertraline vs. placebo on measures of global anxiety. The CGI-Improvement Scale employs a seven point (1 = very much improved to 7 = very much worse) to determine the participant's improvement in response to treatment.
Time frame: 16 weeks
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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Holland Bloorview Kids Rehabilitation Hospital