Proof of Mechanism Study for the Treatment of Social Anhedonia in ASD
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)