Clin2
NCT06081348Possibly a fitRecruiting

Sertraline vs. placebo for anxiety in kids with developmental disorders

Neurodevelopmental DisordersAutismAutism Spectrum DisorderFragile X SyndromeTuberous Sclerosis22Q11 Deletion Syndrome22Q11 DeletionADHD

Treatments studied

Part of Blood & lymphatic, Bones, joints & muscles, Brain & nervous system, Cancer, Genetic & congenital, Heart & circulation, Hormones & metabolism, Mental health clinical trials.

This trial compares sertraline (a common antidepressant) to a placebo (a pill with no medicine) to see which better reduces anxiety in children and teens who also have a neurodevelopmental disorder like autism, ADHD, or Tourette's. The goal is to help you and your child understand if this treatment might offer relief from anxiety.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
130 people
Ages
8 years to 17 years
Study type
Interventional

Who can take part

  • You are between 8 and 17 years old.
  • You have a diagnosed neurodevelopmental disorder, such as autism, ADHD, a tic disorder, Fragile X, tuberous sclerosis, or 22q11 deletion.
  • You have one of these anxiety disorders: separation anxiety, social anxiety, agoraphobia, generalized anxiety, or another significant anxiety problem.
  • Your anxiety is severe enough to have a score of 4 or higher on a standard severity scale.
  • If you take other medications or use behavioral therapy, the doses and programs must have been stable for at least a month (or three months for therapy).
  • You are able to complete study assessments in English.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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