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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


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.


Minimum age: 2 Years. Maximum age: 6 Years. Gender(s): Both.


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


- 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

Page last updated: August 20, 2015

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