Proof of Mechanism Study for the Treatment of Social Anhedonia in ASD

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This project will use the experimental medicine approach of a Phase IIa Proof of Mechanism 16-week, randomized, double-blind, controlled trial of L-DOPA versus placebo administration in combination with a 16 week social skills training group in order to: 1) identify differences in social reward processes in adolescent and young adult ASD participants versus healthy controls as measured by fMRI activation in reward circuitry; 2) provide evidence of dopaminergic moderating effects on social reward components in ASD with greater pre- to post-treatment changes expected in the subjects randomized to L-DOPA versus placebo; 3) examine the hypothesis that baseline readouts of putative dopamine signaling (wanting activation responses) will predict the extent of fMRI reward-related activation changes pre- to post-treatment; and, 4) examine the proposed relationship between pre- to post- L-DOPA fMRI reward changes and changes in individual self-report ratings of social wanting and ratings of videotaped positive affect in a structured interaction with an examiner. The study will enroll 56 participants with DSM-5 ASD between the ages of 13-30 years of age and 18 healthy control participants without histories of psychopathology for baseline comparisons.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Levodopa

Criteria

Inclusion Criteria:

• ages 13 - 30 years inclusive;

• meets diagnostic criteria for ASD by clinical evaluation and ADOS;

• estimated FS IQ >70; 4) English reading ability of 6th grade;

• ability to participate and complete protocol expectations (fMRI scan, testing) in the examining clinician's judgment; and

• planned enrollment and acceptance for the UCLA PEERS® adolescent or young adult social skills training program.

Exclusion Criteria:

• significant perceptual deficits;

• need for continuation or anticipated of use of prohibited dopamine-modifying medications (stimulants, antipsychotics);

• presence of serious behavioral comorbidity such as aggression, major depressive disorder requiring additional intervention, or self-injurious behavior, or current of past history of suspected psychotic disorder;

• history of tic disorder;

• presence of significant medical illness which may impact CNS function.