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L-DOPA + Social Skills Training for Autism Spectrum Disorder (ACEP4 Trial)
ACEP4 Trial 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.
- Autism Spectrum Disorder
ACEP4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACEP4 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2006 Phase 4 trial • 107 Patients • NCT00183625ACEP4 Trial Design
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Who is running the clinical trial?
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- You have a history of tic disorder.Your estimated IQ score is higher than 70.You have significant problems with your senses, like seeing, hearing, or feeling.You have a serious medical condition that could affect your brain function.You have been diagnosed with autism by a doctor and have completed an evaluation called ADOS.People between 13 and 30 years old can participate.You have serious behavioral issues like aggression, severe depression needing extra treatment, or self-harming behavior, or a history of suspected psychotic disorder.
- Group 1: L-DOPA versus Placebo
- Group 2: Social Skills
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment open to the public for this research trial?
"Affirmative. Clinicaltrials.gov indicates that the present recruitment of participants for this clinical trial commenced on June 1st, 2017 and was last modified on October 13th, 2022. 56 patients must be enrolled from a single site to complete the study."
For whom is this clinical trial open to enrollment?
"To partake in this trial, applicants must have anhedonia and range between the ages of 13 to 30. Approximately 56 participants are required for successful completion."
What is the uppermost limit of participants in this trial?
"Affirmative. The trial data available on clinicaltrials.gov confirms that recruitment for this medical study, which launched June 1st 2017, is still ongoing. 56 participants need to be gathered from a single site location."
Are geriatric patients excluded from participation in this clinical research?
"The study's inclusion criteria state that the age range of enrollees should span from 13 to 30 years old. For people below 18, there are 16 other studies available; conversely, those above 65 can avail themselves of 13 different alternatives."
Is Social Skills Training a secure intervention for individuals?
"Since Social Skills Training is currently in Phase 2 of its clinical trial, there is some evidence for safety but still a lack for efficacy. For this reason, our team at Power has assigned it an intermediate score of 2 on the safety scale from 1-3."
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