Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugani, Diane C.
• Treatments: Buspirone

Criteria

Inclusion Criteria:

• Meet study definition for the diagnosis of autistic disorder

• Age 2 to 6 (male or female)

• Informed Consent

Exclusion Criteria:

• 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