ClinicalTrials.gov record NCT06081348

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age8 years old to 17 years old
SexAll
LocationCanada
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 randomized, placebo-controlled pilot study tests sertraline versus placebo for anxiety in children and adolescents with neurodevelopmental disorders. It aims to estimate the effect size on anxiety and to determine the best outcome measures to use across different neurodevelopmental diagnoses. The main outcome is parent-reported anxiety at 16 weeks.

What it is studying. The study is testing whether sertraline given as an oral capsule affects anxiety symptoms compared with a matching placebo in youth with neurodevelopmental disorders. It will also compare several anxiety and global function measures to identify the most useful primary outcome for future trials.

What the researchers hope to learn. Scientific goals: estimate the size of sertraline's effect on anxiety across common and rare neurodevelopmental disorders; identify the best transdiagnostic and diagnosis-specific outcome measures for anxiety. Secondary goals include measuring clinician-rated global improvement (CGI-I), adverse events, quality of life (PedsQL), and whole blood serotonin levels (blood drawn at screening and week 16).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Sertraline
Other
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, you'll be randomly assigned (quadruple-masked) to take either sertraline or a matching placebo capsule for about 16 weeks. Visits include a screening visit and a week-16 visit; parents will complete the SCARED (primary outcome) and the PedsQL, clinicians will complete the CGI-I, and study staff will record side effects using the SMURF. A small blood sample (3 mL) will be taken at screening and again at week 16 to measure whole-blood serotonin. You must be able to swallow capsules and tolerate blood draws; the study team will monitor and record any adverse events.

How the study is structured. Interventional (Phase 2) drug trial with two groups: sertraline and placebo. Participants are randomized into one of the two parallel arms. The trial is quadruple-masked (participant, care provider, investigator, outcomes assessor) and measures outcomes at 16 weeks, with the parent version of the SCARED used as the primary outcome.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in Canada. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on fragile X syndrome

This trial is also listed on this site under tuberous sclerosis complex.

Clinical trials20 trials listed for fragile X syndromeEvery trial the registry lists for fragile X syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in fragile X syndrome researchLatest monthly update: September 2026. Includes: Multiple behavior challenges. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 16, 2024
Primary completion
September 2027 (estimated)
Study completion
September 2027 (estimated)
Target enrollment
130 participants (estimated)
Last updated on registry
Jul 27, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
  • Azrieli Foundation (Funder)
  • Canadian Institutes of Health Research (Funder)
  • Ontario Brain Institute (Funder)
  • McMaster University
  • Western University
  • Queen's University
  • University of Alberta
  • Alberta Health services
  • St. Justine's Hospital
  • Dalhousie University
  • Unity Health Toronto
  • University of Toronto
  • The Hospital for Sick Children
  • Maternal, Infant, Child and Youth Research Network (MICYRN)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (7)

Terms used on this page · explanations by MedicalUpdates.ai

placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
outcome measure
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
concomitant medications
Other medicines a participant takes during the study. Some must be reported; some are restricted.
stable dose
A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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