Comparing Sertraline and Placebo for Treating Anxiety in Children with Neurodevelopmental Disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the effectiveness of sertraline, a selective serotonin reuptake inhibitor, in reducing anxiety symptoms in children and adolescents aged 8-17 with neurodevelopmental disorders such as autism and Fragile X syndrome. Participants will be randomly assigned to receive either sertraline or a placebo, and the study will assess the impact on anxiety levels using both transdiagnostic and diagnosis-specific measures. The goal is to gather preliminary data that could inform larger-scale clinical trials in the future.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Outpatients 8-17 years of age, inclusive
2. 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.
3. 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.
4. 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.
5. 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)
6. If already receiving interventions, must meet the following criteria:

   1. 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
   2. If already receiving stable non-pharmacological behavioural interventions, have stable participation during 3 months prior to screening, and will not electively modify ongoing interventions
7. Ability to complete assessments in English

Exclusion Criteria:

1. Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine)
2. 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.
3. Received more than 2 previous appropriate trials of SSRIs with no adequate response
4. Pregnant females or sexually active females on inadequate contraception
5. 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.
6. Hypersensitivity to sertraline or any components of its formulation
7. On Monoamine Oxidase Inhibitors or pimozide (as per product monograph)
8. On concomitant medications known to significantly increase QT interval where this would result in unacceptable risk per Investigator judgment.
9. Known congenital QT prolongation
10. HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immunity disorder, major depressive episode or psychosis (as required by Health Canada)
11. Unable to tolerate venipuncture
12. Unable to swallow capsules
13. Enrolled in another intervention study

Where it's running

• Alberta Children's Hospital - University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of Alberta-Glenrose
  Edmonton, Alberta, Canada Recruiting
• McMaster University
  Hamilton, Ontario, Canada Recruiting
• Queen's University
  Kingston, Ontario, Canada Recruiting
• University of Western Ontario, Lawson Health Research Institute
  London, Ontario, Canada Recruiting
• Holland Bloorview Kids Rehabilitation Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr. Evdokia Anagnostou — Holland Bloorview Kids Rehab Hospital
• Study coordinator: Faiza Khawaja
• Email: fkhawaja@hollandbloorview.ca
• Phone: 4164256220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.