Autism Spectrum DisorderPhase 2NCT06826326
Neuroimaging of Escitalopram in Autism Spectrum Disorder
A Phase 2 study testing Escitalopram 10mg in people with Autism Spectrum Disorder, run by Kathryn Unruh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Escitalopram 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All participants must meet all inclusion criteria:
- 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.
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- 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.
Who cannot join
- 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.
- Participant has a history of any severe or unstable psychiatric condition (e.g., schizophrenia or other psychotic disorder, bipolar disorder, major depressive disorder) that, in the opinion of the Investigator, could confound the interpretation of the study results or put the subject at undue risk. An acute episode of a mood disorder will be considered exclusionary; a participant with a history of mild to moderate mood disorder may be included in the study under the discretion of the Investigator. Other stable psychiatric conditions are permitted at the discretion of the Investigator (e.g., attention deficit hyperactivity disorder, generalized anxiety disorder, etc.).
- 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.
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- 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.
- Subject has had a seizure within the past 12 months. Individuals with seizure disorders who are on stable seizure medications (i.e., without seizures in past 12 months) are permitted at the discretion of the Investigator.
- Subject is pregnant or breast-feeding, or planning to become pregnant or breastfeed while enrolled in this study or within 3 months after the last dose of study drug.
- Subject has current evidence, or a history within the previous 3 months prior to screening, of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, that, in the opinion of the Investigator, would jeopardize the safe participation of the subject in the study.
- Subject has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence).
- Subject has a known history of a positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test.
- Subject has COVID-19 vaccination status that prevents them from participating at study locations according to the institutional, local, or state guidelines at that study site.
- Subject has other clinically significant laboratory abnormalities that, in the opinion of the Investigator, would jeopardize the safe participation of the study subject.
- Subject is free of any medication that may affect cognitive or motor performance, as evaluated by the Investigator.
- Subject or immediate family member has a history of kidney disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hoglund Biomedical Imaging Center
Kansas City, Kansas, 66103
About this study
Official title: A 'Proof of Concept' Study to Identify Neural Target Engagement of Escitalopram in Adolescents With 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 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.
Read the detailed description
This study is a randomized placebo-controlled, cross-over design evaluating the effects of escitalopram (Lexapro®) on behavioral inflexibility in autism spectrum disorder (ASD). The trial will be conducted on individuals with ASD aged 12-17 years old.
The neural target engagement experiment will use a randomized, placebo-controlled, cross-over design. Within one month after completing the Screening Visit, participants will be randomized by the statistician, in communication with the site pharmacy, to take a single dose of either escitalopram 10 mg or placebo (Visit 2) three hours before beginning the functional MRI. A minimum of one week later (Visit 3), participants will take the other medication (placebo or escitalopram 10 mg) three hours before beginning the functional MRI.
The primary objective of this 'proof of concept' study is to identify neural target engagement of escitalopram in adolescents with ASD.
Primary Objective 1. Neural target engagement: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on blood-oxygen-level dependent (BOLD) activation during a rewarded inhibitory control functional MRI (fMRI) task that has previously shown to be sensitive to individual differences in restricted and repetitive behavior (RRB) severity in ASD (preliminary data).
Primary Objective 2. Behavioral target engagement-inhibitory control: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on behavioral inflexibility during a rewarded inhibitory control task that has previously shown to be sensitive to individual differences in RRB severity in ASD (preliminary data).
Secondary Objective 1. Neural target engagement: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on blood-oxygen-level dependent (BOLD) activation during a rewarded prosaccade functional MRI (fMRI) task.
Secondary Objective 2. Behavioral target engagement-prosaccades: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on reflexive motor behavior during a rewarded prosaccade task.
Secondary Objective 3. Behavioral target engagement-reversal learning: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on behavioral flexibility assessed with a probabilistic reversal learning task.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Escitalopram 10mg, Placebo
- Keywords
- escitalopram, autism spectrum disorder, repetitive behavior, fMRI
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 10mgDrug
oral administration of escitalopram 10 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram then Placebo | Experimental | participants will receive escitalopram during visit 2 and placebo during visit 3 Receives: Drug: Escitalopram 10mg; Drug: Placebo |
| Placebo then Escitalopram | Experimental | participant will receive placebo during visit 2 and escitalopram during visit 3 Receives: Drug: Escitalopram 10mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Visit 2 (1 day to 1 month after Screening/Visit 1) and Visit 3 (5 days to 3 weeks after Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start28 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathryn Unruh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathryn Unruh, University of Kansas
- Investigators
- Kathryn E Unruh, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826326
- Sponsor's protocol ID
- STUDY00160812
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 'Proof of Concept' Study to Identify Neural Target Engagement of Escitalopram in Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06826326
- Acronym / sponsor ID
- STUDY00160812
- Conditions
- Autism Spectrum Disorder
- Keywords
- escitalopram, autism spectrum disorder, repetitive behavior, fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Kathryn UnruhUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized placebo-controlled, cross-over design evaluating the effects of escitalopram (Lexapro®) on behavioral inflexibility in autism spectrum disorder (ASD). The trial will be conducted on individuals with ASD aged 12-17 years old.
The neural target engagement experiment will use a randomized, placebo-controlled, cross-over design. Within one month after completing the Screening Visit, participants will be randomized by the statistician, in communication with the site pharmacy, to take a single dose of either escitalopram 10 mg or placebo (Visit 2) three hours before beginning the functional MRI. A minimum of one week later (Visit 3), participants will take the other medication (placebo or escitalopram 10 mg) three hours before beginning the functional MRI.
The primary objective of this 'proof of concept' study is to identify neural target engagement of escitalopram in adolescents with ASD.
Primary Objective 1. Neural target engagement: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on blood-oxygen-level dependent (BOLD) activation during a rewarded inhibitory control functional MRI (fMRI) task that has previously shown to be sensitive to individual differences in restricted and repetitive behavior (RRB) severity in ASD (preliminary data).
Primary Objective 2. Behavioral target engagement-inhibitory control: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on behavioral inflexibility during a rewarded inhibitory control task that has previously shown to be sensitive to individual differences in RRB severity in ASD (preliminary data).
Secondary Objective 1. Neural target engagement: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on blood-oxygen-level dependent (BOLD) activation during a rewarded prosaccade functional MRI (fMRI) task.
Secondary Objective 2. Behavioral target engagement-prosaccades: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on reflexive motor behavior during a rewarded prosaccade task.
Secondary Objective 3. Behavioral target engagement-reversal learning: Evaluate the impact of a single dose of escitalopram 10 mg versus placebo, in a cross-over design, on behavioral flexibility assessed with a probabilistic reversal learning task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram then Placebo | Experimental | Drug: Escitalopram 10mg, Drug: Placeboparticipants will receive escitalopram during visit 2 and placebo during visit 3 |
| Placebo then Escitalopram | Experimental | Drug: Escitalopram 10mg, Drug: Placeboparticipant will receive placebo during visit 2 and escitalopram during visit 3 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
- Participant has a history of any severe or unstable psychiatric condition (e.g., schizophrenia or other psychotic disorder, bipolar disorder, major depressive disorder) that, in the opinion of the Investigator, could confound the interpretation of the study results or put the subject at undue risk. An acute episode of a mood disorder will be considered exclusionary; a participant with a history of mild to moderate mood disorder may be included in the study under the discretion of the Investigator. Other stable psychiatric conditions are permitted at the discretion of the Investigator (e.g., attention deficit hyperactivity disorder, generalized anxiety disorder, etc.).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram 10mgoral administration of escitalopram 10 mg | Drug | Escitalopram then Placebo, Placebo then Escitalopram |
| PlaceboPlacebo | Drug | Escitalopram then Placebo, Placebo then Escitalopram |
Primary outcome
Rewarded Antisaccade task
Time frame: At Visit 2 (1 day to 1 month after Screening/Visit 1) and Visit 3 (5 days to 3 weeks after Visit 2)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn E Unruh, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram 10mg in people with Autism Spectrum Disorder, run by Kathryn Unruh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rewarded Antisaccade task (time frame: At Visit 2 (1 day to 1 month after Screening/Visit 1) and Visit 3 (5 days to 3 weeks after Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.