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

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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age8-17

SponsorHolland Bloorview Kids Rehabilitation Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

Sertraline
Placebo

Treatment groups

130 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Holland Bloorview Kids Rehabilitation Hospital

Lead sponsor

Azrieli Foundation (Funder)

Collaborator

Canadian Institutes of Health Research (Funder)

Collaborator

Ontario Brain Institute (Funder)

Collaborator

McMaster University

Collaborator

Western University

Collaborator

Queen's University

Collaborator

University of Alberta

Collaborator

Alberta Health services

Collaborator

St. Justine's Hospital

Collaborator

Dalhousie University

Collaborator

Unity Health Toronto

Collaborator

University of Toronto

Collaborator

The Hospital for Sick Children

Collaborator

Maternal, Infant, Child and Youth Research Network (MICYRN)

Collaborator

Source ClinicalTrials.gov