Status:
UNKNOWN
Proof of Mechanism Study for the Treatment of Social Anhedonia in ASD
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
ASD
Eligibility:
All Genders
13-30 years
Phase:
PHASE2
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 wi...
Detailed Description
Participants will comprise two groups: 1) 56 (male and female) adolescents and young adults likely to meet inclusion/exclusion confirmed by study assessment who will be outpatients, ages 13 to 30 year...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03243552
Start Date
June 1 2017
End Date
December 1 2023
Last Update
June 28 2023
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095