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

Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Study ID
NCT06081348
Phase
PHASE2
Status
Recruiting
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Conditions

  • 22Q11 Deletion
  • 22Q11 Deletion Syndrome
  • ADHD
  • ADHD - Combined Type
  • ADHD Predominantly Inattentive Type
  • ADHD, Predominantly Hyperactive - Impulsive
  • Anxiety
  • Anxiety Disorders
  • Autism
  • Autism Spectrum Disorder
  • Fragile X Syndrome
  • Neurodevelopmental Disorders
  • Tic Disorders
  • Tourette Syndrome
  • Tourette Syndrome in Adolescence
  • Tourette Syndrome in Children
  • Tuberous Sclerosis

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Sertraline — DRUG
    Oral capsule (25mg, 50mg, 100mg, 200mg)
  • Placebo — OTHER
    Oral placebo capsule

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Nov 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sertraline
  • Placebo Comparator: Placebo

Primary Outcome Measure

The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version [ Time Frame: 16 weeks ]

Central Contacts

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