← Back to Search

Dopamine Precursor

L-DOPA + Social Skills Training for Autism Spectrum Disorder (ACEP4 Trial)

Phase 2

Waitlist Available

Led By James T McCracken, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8 (midpoint), week 16 (4 month/end of study)

Summary

This trial will use L-DOPA or placebo to study social reward processes in adolescents and young adults with ASD, and how dopamine affects these processes. It will enroll 56 participants with ASD and 18 healthy controls.

Eligible Conditions

Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8 (midpoint), week 16 (4 month/end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8 (midpoint), week 16 (4 month/end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 (midpoint), week 16 (4 month/end of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fMRI: Social Reward Task from Baseline to week 16 (4 months)

Secondary study objectives

Change on Adult Behavior Checklist (ABCL)

Change on Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

Change on Anticipatory and Consummatory Interpersonal Pleasure Scale Adolescent (ACIPS-A)

+5 more

Side effects data

From 2006 Phase 4 trial • 107 Patients • NCT00183625

23%

Hospitalization

100%

80%

60%

40%

20%

Study treatment Arm

Olanzapine Treatment

Risperidone Treatment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Social SkillsExperimental Treatment2 Interventions

All participants will receive 16-week manualized social skills training.

Group II: L-DOPA versus PlaceboActive Control2 Interventions

L-DOPA or placebo (1:1 randomization). Dosing will begin at 25mg carbidopa/100mg L-DOPA in 3 divided doses, with a fixed-flexible titration schedule, allowing dose increases once per week of 100mg L-DOPA. Maximum dose is 600mg/d.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Social Skills Training

2022

Completed Phase 4

~2680

Do I qualify?Apply below to find out