Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy

Completed · Phase 1/Phase 2

Conditions studied: Autism

In brief

The purpose of this study is to determine the efficacy, safety, and population pharmacokinetics and determinants of drug responses to buspirone in children with autism using a randomized, double blind, cross over study in children ages 2 to 6 years.

Key facts

Study ID

NCT00166621

Run by

Chugani, Diane C.

People needed

20

Starts

2004-03-01

Expected to finish

2005-08-01

Last updated by the study team

2011-07-20

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet study definition for the diagnosis of autistic disorder
• Age 2 to 6 (male or female)
• Informed Consent

You may not qualify if…

• Clinical or lab evidence of renal or hepatic disease
• Treatment with any medication known to alter the activity of the CYP3A4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 3 months
• Use of centrally acting drugs during the 6 weeks prior or during the study
• Presence or history of neurological disorders, including seizure disorders

Where it is running

• PET Center/Children's Hospital of Michigan — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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