Sertraline Vs. Placebo in the Treatment of Anxiety in Children and AdoLescents with NeurodevelopMental Disorders

Launched by ANAGNOSTOU, EVDOKIA, M.D. · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sertraline on anxiety in children and teenagers with various neurodevelopmental disorders, such as Autism Spectrum Disorder, ADHD, and Fragile X Syndrome. Currently, there are no approved medications specifically for treating anxiety in these young people, so researchers want to see if sertraline can help reduce anxiety symptoms. This study will also help identify the best ways to measure anxiety in future research.

To be eligible for the trial, participants need to be between 8 and 17 years old and must have a diagnosed neurodevelopmental disorder along with an anxiety disorder. They should be able to communicate verbally and agree to use birth control if they are sexually active. During the study, participants will receive either sertraline or a placebo (a pill with no active medication) and will be monitored for changes in their anxiety levels. It’s important to know that the trial is currently recruiting participants, and those who join will contribute to understanding how to better treat anxiety in children with these conditions.

Gender

ALL

Eligibility criteria

• 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. Have at least phrase speech, to allow for some self-report. So that results can be generalized to children and youth with NDD and various levels of ability, no IQ cut-off will be employed. Full-scale IQ (as measured by the Stanford-Binet) is measured to explore its effect on efficacy and safety\*
• 7. 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
• • 8. Ability to complete assessments in English/French
• 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