Escitalopram for Autism

Recruiting in Palo Alto (17 mi)

Overseen ByKathryn E Unruh, PhD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kathryn Unruh

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to evaluate the acute effects of escitalopram (Lexapro®) on select brain networks during task-based functional magnetic resonance imaging (fMRI) in adolescent individuals with autism spectrum disorder (ASD). We hope to learn more about the acute effects of escitalopram and how it might be used to treat inflexible thinking or rigid-compulsive behavior that can be associated with restricted and repetitive behaviors in adolescents with ASD. Participants will: * Attend 3 visits to complete tests of thinking abilities and fill out surveys about their health and behavior * Be randomly assigned to receive escitalopram at one of the first two visits after screening and a placebo at the other visit. * Complete 2 MRI scans while doing a reward-based task that tracks eye movement

Eligibility Criteria

This trial is for adolescents with Autism Spectrum Disorder who can undergo MRI scans and complete cognitive tests. They should not have any health conditions that interfere with the study or be taking medications that affect brain function.

Inclusion Criteria

I am between 12 and 17 years old.

I can swallow pills with liquid.

I can take my medication by myself or have someone who can do it for me.

I have been diagnosed with Autism Spectrum Disorder by a licensed professional.

I agree to not change my current medications or treatments during the study.

Exclusion Criteria

I have a personal or family history of long QT syndrome or sudden death.

I have not had electroconvulsive therapy in the last 6 months.

I haven't used any experimental drugs or devices in the last 3 months.

I have tested positive for hepatitis C or HIV.

Participant Groups

The trial is testing the effects of a medication called Escitalopram on brain activity in adolescents with ASD. Participants will receive either Escitalopram or a placebo at random, and their brain networks will be monitored through fMRI while they perform specific tasks.

2Treatment groups

Experimental Treatment

Group I: Placebo then EscitalopramExperimental Treatment2 Interventions

participant will receive placebo during visit 2 and escitalopram during visit 3

Group II: Escitalopram then PlaceboExperimental Treatment2 Interventions

participants will receive escitalopram during visit 2 and placebo during visit 3