5 Participants Needed

Escitalopram for Autism

KE
SP
Overseen BySydney P Gardner
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

Do I have to stop taking my current medications for the trial?

The trial requires participants to continue their current medications and not make any changes to them during the study.

Is escitalopram generally safe for humans?

Escitalopram has been studied for safety in various conditions like depression and anxiety, showing it is generally well-tolerated in both adults and adolescents. Some studies report it as safe when used alone or with other treatments, with common side effects being mild and including nausea and headache.12345

How does the drug escitalopram differ from other treatments for autism?

Escitalopram is unique because it is a selective serotonin reuptake inhibitor (SSRI) primarily used to treat depression and anxiety, and its use for autism is novel as there are no standard treatments specifically approved for autism. Its mechanism of action involves increasing serotonin levels in the brain, which may help with mood and anxiety symptoms that can be present in autism.56789

Research Team

KE

Kathryn E Unruh, PhD

Principal Investigator

University of Kansas

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.
Participant must be able to speak and understand English in order to complete study measures
Parent, primary caregiver, or other adult informant must speak and understand English to complete study measures
See 7 more

Exclusion Criteria

Subject has a body mass index (BMI) <17 or >40 at Screening
I am unable to follow all the study's requirements.
Participant is an employee of an investigator with direct involvement in the proposed study or other studies under the direction of a study investigator, or is a family member of an investigator
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 month
1 visit (in-person)

Treatment

Participants receive a single dose of escitalopram or placebo and undergo fMRI scans

1-3 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Escitalopram
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kathryn Unruh

Lead Sponsor

Trials
1
Recruited
5+

Findings from Research

In a study of 131 patients with various affective disorders, escitalopram was found to be well tolerated over a 14-month period, with only 5.3% reporting side effects, primarily insomnia and nausea.
There was no significant difference in tolerability between patients receiving escitalopram as monotherapy or as an augmentative treatment, indicating its safety in both treatment approaches.
Escitalopram tolerability as mono- versus augmentative therapy in patients with affective disorders: a naturalistic study.Dell'osso, B., Arici, C., Dobrea, C., et al.[2022]
Escitalopram is effective and well tolerated for both short- and long-term treatment of generalized anxiety disorder, based on evidence from randomized placebo-controlled and comparator-controlled trials.
Compared to benzodiazepines and the SSRI paroxetine, escitalopram offers advantages in treating generalized anxiety disorder, making it a preferred option for patients.
Escitalopram in the treatment of generalized anxiety disorder.Baldwin, DS., Nair, RV.[2013]
Escitalopram, the S-enantiomer of citalopram, effectively inhibits serotonin reuptake, which is crucial for its antidepressant effects, with minimal interaction with other receptors, ensuring a better safety profile.
Clinical trials show that a daily dose of 10 mg of escitalopram is as effective as 40 mg of citalopram, highlighting its efficacy and tolerability, making it a refined option for treating depression and anxiety.
Escitalopram: A New SSRI for the Treatment of Depression in Primary Care.Culpepper, L.[2020]

References

Escitalopram tolerability as mono- versus augmentative therapy in patients with affective disorders: a naturalistic study. [2022]
Escitalopram in the treatment of adolescent depression: a randomized, double-blind, placebo-controlled extension trial. [2021]
Treatment of generalized anxiety disorder with escitalopram: pooled results from double-blind, placebo-controlled trials. [2022]
A randomized, controlled, pilot study of acamprosate added to escitalopram in adults with major depressive disorder and alcohol use disorder. [2021]
A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression. [2022]
Escitalopram in the treatment of generalized anxiety disorder. [2013]
Escitalopram: A New SSRI for the Treatment of Depression in Primary Care. [2020]
Escitalopram : a review of its use in the management of major depressive and anxiety disorders. [2022]
Escitalopram: in the treatment of major depressive disorder in adolescent patients. [2021]