Status:
COMPLETED
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder
Lead Sponsor:
Chugani, Diane C.
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Autistic Disorder
Eligibility:
All Genders
2-6 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism ...
Detailed Description
This is a multi-center, randomized, placebo-controlled, double-masked study of 166 evaluable participants taking buspirone twice daily for 6 months. Children aged 2-6 years with autism will be randomi...
Eligibility Criteria
Inclusion
- Participants: must meet the study definition for diagnosis of autistic disorder as determined by clinical diagnosis based upon DSM-IV criteria, the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) performed at baseline 1. ADI-R will be conducted by trained study staff at Baseline 1 Visit. If the participant has had an ADI-R in the past 12 months, this will be accepted provided the person administering and scoring the test is site personnel validated for the study.
- Age 2 to less than 6 years, male and female.
- Parent/Legal Guardian/Caregiver must be able to understand , read and speak English
- Written Informed Consent.
Exclusion
- Presence or history of neurological disorders, including seizure disorders (abnormal EEG without seizures will not be excluded), PKU, tuberous sclerosis, Rett syndrome, Fragile X syndrome, Down Syndrome and traumatic brain injury.
- Other medical or behavioral problems requiring medications which are centrally active.
- Clinical or laboratory evidence of renal or hepatic disease (SGPT, GGT \> 2 x normal value, and serum creatinine \> 1.5 x normal value).
- 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 2 months and for the duration of the study is prohibited.
- Use of centrally acting drugs during the 6 weeks prior or during the study. These drugs include but are not limited to neuroleptics, benzodiazepines, anticonvulsants and antidepressants. Shorter times may be considered depending on the half life of the drug.
- Prior treatment for periods longer than two weeks with buspirone or selective serotonin reuptake inhibitors. This includes herbal substances such as St John's Wort which have similar pharmacological actions.
- Known allergies to study medication.
- Unable to provide the required blood samples.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00873509
Start Date
May 1 2009
End Date
January 1 2015
Last Update
July 26 2016
Active Locations (6)
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1
University California Davis M.I.N.D. Institute
Sacramento, California, United States, 95817
2
Children's Hospital of Michigan Wayne State University
Detroit, Michigan, United States, 48201
3
New York University Langone Medical Center
New York, New York, United States, 10016
4
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106