Escitalopram for Autism

Overseen By Sydney P Gardner

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Kathryn Unruh

Must not be taking: MAO inhibitors, Psychotropics

Disqualifiers: Severe psychiatric conditions, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the medication escitalopram (an antidepressant) affects brain activity in adolescents with autism spectrum disorder (ASD). Researchers focus on its potential to help with inflexible thinking and repetitive behaviors. Participants will receive both escitalopram and a placebo during different visits to assess their effects. Teens diagnosed with autism who experience challenges with repetitive behaviors may be suitable for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that escitalopram is likely to be safe for humans?

A previous study with 58 children and teens with autism found that escitalopram was generally well-tolerated. Some participants experienced side effects, with headaches and upset stomach being the most common. However, these side effects were not severe for most participants.

Research has also shown that some individuals may process escitalopram faster than usual, potentially leading to more side effects, especially if the dose increases quickly.

It is important to note that the FDA has already approved escitalopram for treating depression and anxiety in other groups. This approval indicates its safety for those conditions, although individuals with autism might respond differently. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Escitalopram is unique because it offers a novel approach for treating autism by targeting serotonin levels in the brain. Unlike standard treatments, which often focus on behavioral therapies or antipsychotic medications, escitalopram is an SSRI (selective serotonin reuptake inhibitor) that specifically aims to balance the chemicals that affect mood and social behavior. Researchers are excited about this treatment because it could provide a more targeted and potentially effective option for managing symptoms of autism, particularly in improving social interaction and reducing anxiety.

What evidence suggests that escitalopram might be an effective treatment for autism?

Studies have shown that escitalopram, a type of medication known as an SSRI, may help with symptoms in people with autism spectrum disorder (ASD). One study found escitalopram effective in treating certain behaviors in children and teens with autism, such as rigid thinking and repetitive actions, which are common in ASD. Another report highlights that medications like escitalopram are widely used for ASD, although individual responses can vary. While escitalopram is not specifically approved for autism, these findings suggest it may improve certain symptoms in those affected by the condition. Participants in this trial will receive escitalopram and a placebo in different sequences to evaluate its effects on ASD symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Kathryn E Unruh, PhD

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Escitalopram

Trial Overview

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.

How Is the Trial Designed?

Group I: Placebo then Escitalopram Experimental Treatment 2 Interventions

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

Group II: Escitalopram then Placebo Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Kathryn Unruh

Lead Sponsor

Trials

1

Recruited

5+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram: A New SSRI for the Treatment of Depression in Primary Care. Culpepper, L.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram in the treatment of generalized anxiety disorder. Baldwin, DS., Nair, RV.[2013]

Escitalopram, the active S-enantiomer of citalopram, significantly improves depressive symptoms in patients with major depressive disorder (MDD) compared to placebo, with effects noticeable as early as 1-2 weeks into treatment, based on several 8-week, randomized, placebo-controlled studies.

The drug has a favorable safety profile, with mild and transient side effects similar to those of placebo, making it a suitable first-line treatment for MDD and potentially beneficial for anxiety disorders as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram : a review of its use in the management of major depressive and anxiety disorders. Waugh, J., Goa, KL.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2937270/

A Pharmacogenetic Study of Escitalopram in Autism ...

The current manuscript extends this study to report on a total of 58 subjects with ASDs between the ages of 5 and 17, who received an SSRI, escitalopram, in a ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06826326

Neuroimaging of Escitalopram in Autism Spectrum Disorder

The goal of this clinical trial is to evaluate the acute effects of escitalopram (Lexapro®) on select brain networks during task-based functional magnetic ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4591203/

Escitalopram pharmacogenetics: CYP2C19 relationships ...

Selective serotonin reuptake inhibitors such as escitalopram are commonly used to treat patients with Autism Spectrum Disorder (ASD), but there are individual ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0890856709614854

An Open-Label Trial of Escitalopram in Pervasive ...

This open-label study found escitalopram to be useful in treating some difficulties common in PDDs. A wide variability in dose was found that could not be ...

5.

psychiatrist.com

psychiatrist.com/jcp/selective-serotonin-reuptake-inhibitors-autism-review/

Selective Serotonin Reuptake Inhibitors in Autism

This article reviews the available data on the efficacy and tolerability of SSRIs in individuals with autism spectrum disorders. Objectives for ...

6.

psychiatrist.com

psychiatrist.com/pdf/safety-issues-with-drug-therapies-for-autism-spectrum-disorders-pdf/

Safety Issues With Drug Therapies for Autism Spectrum ...

It should be appreciated that individuals with autism spectrum disorders may be at higher risk to experience neurologic side effects associated with clomip-.

7.

womensmentalhealth.org

womensmentalhealth.org/posts/autism-spectrum-disorders-and-ssris/

Autism Spectrum Disorders and SSRIs

This study found a greater risk of autism spectrum disorders among children of SSRI users compared to non-users during pregnancy: 6.7% of the children with ASD ...