Sertraline Treatment for Anxiety in Children and Adolescents with Neurodevelopmental Disorders A Randomized, Placebo-Controlled Phase 2 Trial

What this Trial Is About

Researchers are investigating whether sertraline, a selective serotonin reuptake inhibitor, can reduce anxiety in children and adolescents aged 8 to 17 years who have neurodevelopmental disorders, including autism, ADHD, tic disorders, and certain genetic conditions. This Phase 2 randomized, placebo-controlled trial aims to estimate sertralines effect size on anxiety reduction and identify the best measures to use in future larger trials. Anxiety disorders studied include separation anxiety, social anxiety, agoraphobia, generalized anxiety disorder, and unspecified anxiety disorder. Participants will be randomly assigned to receive either sertraline or a matching placebo capsule. Sertraline capsules come in doses of 25mg, 50mg, 100mg, or 200mg, taken orally. The treatment period lasts 16 weeks, with dosing adjusted as needed. The study monitors both common and rare neurodevelopmental disorders across a parallel design. During the study, participants will complete anxiety assessments including the Screen for Child Anxiety Related Emotional Disorders SCARED parent version, a Clinical Global Impressions improvement scale, quality of life questionnaires, and blood tests for serotonin levels. Safety is monitored through adverse event reporting. The research team will measure anxiety changes over the 16-week treatment. Participants will have regular visits during the study and their responses to treatment will be closely observed.

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