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Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents with NeurodevelopMental Disorders: The CALM Study

Autism | Tuberous Sclerosis | Anxiety Disorder | Fragile X Syndrome | Tic | ADHD (Inattention)

This randomized controlled trial is to see the effects of a drug called sertraline on anxiety in children and adolescents with Neurodevelopmental Conditions / Disorders (NDDs): including Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Tic Disorders, Fragile X syndrome, Tuberous Sclerosis, 22q11 deletions.

Though Sertraline has been studied in children, and adolescents with obsessive compulsive disorder (OCD) and with major depression, research is needed to confirm whether sertraline can help improve anxiety in children and youth with NDDs.

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Participation Requirements

  • Sex:

    Male, Female, Intersex

  • Eligible Ages:

    8 to 17

Participation Criteria

Inclusion Criteria:
To be eligible for this study, the participant needs to be:
1. 8-17 years old
2. Female youth who are sexually active and agree to use birth control
3. Have at least one diagnosis of ASD, ADHD, Tic Disorders, or a genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions.
4. Have at least one of the conditions: Separation Anxiety Disorder, Social Anxiety Disorder, Agoraphobia, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder.
5. Have some ability to speak.
6. If already receiving treatments, must meet the following criteria:
a. If receiving medication, must be on a stable dose.
b. If already receiving stable non-pharmacological behavioural treatments, have stable participation during 3 months prior to screening and will continue after finishing this research.
7. Proficient in speaking and reading English
8. Parent(s) / caregiver(s) willing to complete questionnaires about their child/youth

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB24-0108