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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
5
oral administration of escitalopram 10 mg
Placebo
Hoglund Biomedical Imaging Center
Kansas City, Kansas, United States
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.
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)
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