Neuroimaging of Escitalopram in Autism Spectrum Disorder

NCT06826326 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00160812
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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 a reward-based task that tracks eye movement, either during MRI or in laboratory environment.

Conditions

Autism Spectrum Disorder

Keywords

escitalopram; autism spectrum disorder; repetitive behavior; fMRI

Outcome Measures

Primary Outcomes (1)

• Rewarded Antisaccade task

  During the rewarded antisaccade task (R-ANTI), participants are instructed to look away from a peripheral target and to the mirror location in the opposite hemifield (antisaccade) and avoid looking toward the peripheral target (prosaccade). Two trial types are presented: reward and no-reward. Number of prosaccades is compared between reward and no-reward trial types.

  At Visit 2 (1 day to 1 month after Screening/Visit 1) and Visit 3 (5 days to 3 weeks after Visit 2)

Study Arms (2)

Escitalopram then Placebo

EXPERIMENTAL

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

Drug: Escitalopram 10mg; Drug: Placebo

Placebo then Escitalopram

EXPERIMENTAL

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

Drug: Escitalopram 10mg; Drug: Placebo

Interventions

Escitalopram 10mg DRUG

oral administration of escitalopram 10 mg

Escitalopram then Placebo; Placebo then Escitalopram

Placebo DRUG

Placebo

Escitalopram then Placebo; Placebo then Escitalopram

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participant must be at least 12 years old and no greater than 17 years old.
• A parent or guardian must sign an informed consent document indicating understanding the protocol and procedures and willingness to participate in full. Signed assent indicating understanding and willingness to participate is required of participants under 18 years of age (all participants).
• Participant must have a diagnosis of Autism Spectrum Disorder, according to DSM-5 criteria, made by a licensed study psychiatrist or psychologist and supported by the Autism Diagnostic Observation Schedule 2 (ADOS-2) completed at screening or within the past 12 months by an appropriately trained professional.
• Participant must have a non-verbal IQ of greater than or equal to 70 as determined by the 4-subtest Wechsler Abbreviated Scale of Intelligence.
• Participant must be able to speak and understand English in order to complete study measures.
• Participant must live with a parent, primary caregiver, or other adult informant who can complete study measures on the basis of spending an average of at least 4 hours per day with the participant.
• Parent, primary caregiver, or other adult informant must speak and understand English to complete study measures.
• Participant must be able to self-administer study medication or have parent/caregiver be able to administer study medication.
• Participant must be able to swallow study medication whole with liquid.
• Participant or legally acceptable representative must be willing to continue current medication(s) and behavioral intervention(s) and to not add or change medication(s) or behavioral intervention(s) over the full course of the study.

You may not qualify if:

• Any potential subject who meets any of the following criteria will be excluded from participating in the study unless otherwise specified:
• Participant is judged by the Investigator to be unable to perform or comply with all study specific 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.
• Subject has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 3 or higher (active suicidal ideation with some intent to act, without specific plan) on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at any study visit. In the case that a screened participant exhibits concerns on the C-SSRS that would preclude study participation, the study safety plan outlined in 1.3 Potential Risks will be followed.
• Subject has met DSM-5 criteria for a substance abuse disorder within the last 6 months prior to Screening, except for disorders related to caffeine or nicotine.
• Subject is taking an MAO inhibitor, serotonergic reuptake inhibitor, or serotonergic-norepinephrine reuptake inhibitor or has taken any of these medications within the past 90 days.
• Subject is taking a psychotropic medication or has taken this medication within the past 90 days.
• Subject has received electroconvulsive therapy (ECT) in the last 6 months.
• Subject has received new-onset psychotherapy or has had a change in the intensity of psychotherapy within the 2 months prior to Screening.
• Subject has known allergies, hypersensitivity, or intolerance to escitalopram or its excipients.
• Subject has received an investigational drug or used an investigational medical device within 3 months before the planned start of study or is currently enrolled in an investigational study.
• Subject has a body mass index (BMI) \<17 at Screening.
• Subject has a known history of long QT syndrome or family history of sudden death.
• Subject has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident (CVA) within the last 4 months. Has greater than NYHA Class 2 congestive heart failure or Class 2 angina pectoris, sustained ventricular tachycardia (VT), ventricular fibrillation, torsade de pointes, or syncope due to an arrhythmia.
• Subject has a history of neuroleptic malignant syndrome/serotonin syndrome.

Sponsors & Collaborators

• Kathryn Unruh: lead

Study Sites (1)

Hoglund Biomedical Imaging Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kathryn E Unruh, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 13, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)