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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
13 Years
Maximum Age
30 Years

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.

Join this Trial

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Study Stats
Protocol No.
17-001168
Category
Semel Institute (Psychiatry)
Contact
JENNIFER COWEN
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03243552
For detailed technical eligibility, visit ClinicalTrials.gov.