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

Study acronym: CALM
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from Holland Bloorview Kids Rehabilitation Hospital

Record History

  1. Primary and study completion pushed from Sep 2026 to Sep 2027 Study sites: 8 to 7 · Eligibility criteria shortened, about 50 wordsv6 Show 2 more changesShow less
    • Study sites: 8 to 7
    • Eligibility criteria shortened, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  2. Lead sponsor: Anagnostou, Evdokia, M.D. to Holland Bloorview Kids Rehabilitation Hospital Primary and study completion dates: Mar 2026 to Sep 2026 · Site details revised at 8 of 8 sites · Collaborators revised (14)v5 Show 3 more changesShow less
    • Primary and study completion dates: Mar 2026 to Sep 2026
    • Site details revised at 8 of 8 sites
    • Collaborators revised (14)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Active, Not Recruiting to Recruiting Start date: Jun 10, 2024 to Sep 16, 2024 · Study sites: 7 to 8 · Primary and study completion dates: Jun 2026 to Mar 2026v4 Show 3 more changesShow less
    • Start date: Jun 10, 2024 to Sep 16, 2024
    • Study sites: 7 to 8
    • Primary and study completion dates: Jun 2026 to Mar 2026
  4. Primary and study completion dates: Apr 2024 to Jun 2026 Start date changed from estimate of Oct 2023 to Jun 10, 2024 · Trial status: Not Yet Recruiting to Active, Not Recruiting · Eligibility criteria shortened, about 11 words · 3 morev3 Show 6 more changesShow less
    • Start date changed from estimate of Oct 2023 to Jun 10, 2024
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints revised (5)
    • Site contacts updated at 6 of 7 sites
    • Collaborators revised (14)

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06081348
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)
Conditions Neurodevelopmental Disorders, Autism, Autism Spectrum Disorder, Fragile X Syndrome, Tuberous Sclerosis, 22Q11 Deletion Syndrome, 22Q11 Deletion, ADHD +9 more
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov