Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder
Information source: Chugani, Diane C.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autistic Disorder
Intervention: Buspirone (Drug); Buspirone (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Chugani, Diane C. Official(s) and/or principal investigator(s): Diane C Chugani, PhD, Principal Investigator, Affiliation: Wayne State University
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 Diagnostic Observation Schedule (ADOS) Composite Total scores
compared to placebo at 6 months.
Clinical Details
Official title: A Randomized, Placebo-controlled, Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months.
Secondary outcome: To evaluate the effects of twice-daily oral buspirone on the ADOS Composite calibrated severity score, social behavior, repetitive behavior, language, sensory dysfunction and anxiety.To determine whether there are age group differences in the effects of buspirone on social interaction, repetitive behavior, language, sensory dysfunction and anxiety. To determine whether there is a difference in the incidence of side effects and long term safety between the buspirone and placebo groups, and between the different dose groups. To determine whether the whole brain PET measure of serotonin synthesis capacity is a predictor of buspirone effect. To determine whether blood serotonin concentration is a predictor of buspirone effect.
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 randomized to receive one of three treatments: 2. 5mg, 5. 0mg, or matched placebo.
The placebo controlled trial will be followed by an optional follow-up trial to assess the
long term safety of buspirone. In addition, a PET scan of serotonin synthesis and plasma
serotonin will be measured at baseline to determine whether these measures are predictors of
drug response. This trial is aimed at the core features of autism. The outcome measures
for efficacy will be examiner and parent ratings on psychological tests and questionnaires.
The outcome measure for the primary objective will be the Autism Diagnostic Observation
Scale (ADOS) Composite Total score. The behavioral outcomes for the secondary aims are
delineated in the study design.
Eligibility
Minimum age: 2 Years.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
University California Davis M.I.N.D. Institute, Sacramento, California 95817, United States
Children's Hospital of Michigan Wayne State University, Detroit, Michigan 48201, United States
New York University Langone Medical Center, New York, New York 10016, United States
Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio 44195, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States
University of Texas Southwestern, Dallas, Texas 75390, United States
Additional Information
Starting date: May 2009
Last updated: February 12, 2015
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