NCT00873509

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 Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2009

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

5.7 years

First QC Date

March 30, 2009

Last Update Submit

July 25, 2016

Conditions

Autistic Disorder

Keywords

Autism

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline 1, Week 24

Secondary Outcomes (5)

  • 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.

    Baseline 1, Week 24 and Week 48

  • To determine whether there are age group differences in the effects of buspirone on social interaction, repetitive behavior, language, sensory dysfunction and anxiety.

    Baseline 1, Week 1, Week 24, Week 48

  • 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.

    Duration of the study

  • To determine whether the whole brain PET measure of serotonin synthesis capacity is a predictor of buspirone effect.

    Baseline 2

  • To determine whether blood serotonin concentration is a predictor of buspirone effect.

    Baseline 2

Study Arms (3)

1

EXPERIMENTAL

Buspirone 2.5 mg

Drug: Buspirone

2

EXPERIMENTAL

Buspirone 5.0 mg

Drug: Buspirone

3

PLACEBO COMPARATOR

Placebo match

Drug: Placebo

Interventions

BuspironeDRUG

Buspirone liquid, 2.5 mg in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study

1
PlaceboDRUG

Placebo liquid, in 1 ml, once per day in the evening for the first week of administration and thereafter twice a day 12 hours apart for the entire study

3

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University California Davis M.I.N.D. Institute

Sacramento, California, 95817, United States

Location

Children's Hospital of Michigan Wayne State University

Detroit, Michigan, 48201, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Lerner College of Medicine

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Chugani DC, Chugani HT, Wiznitzer M, Parikh S, Evans PA, Hansen RL, Nass R, Janisse JJ, Dixon-Thomas P, Behen M, Rothermel R, Parker JS, Kumar A, Muzik O, Edwards DJ, Hirtz D; Autism Center of Excellence Network. Efficacy of Low-Dose Buspirone for Restricted and Repetitive Behavior in Young Children with Autism Spectrum Disorder: A Randomized Trial. J Pediatr. 2016 Mar;170:45-53.e1-4. doi: 10.1016/j.jpeds.2015.11.033. Epub 2015 Dec 30.

    PMID: 26746121RESULT

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds

Study Officials

  • Diane C Chugani, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Clinical Pharmacology and Toxicology

Study Record Dates

First Submitted

March 30, 2009

First Posted

April 1, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(6)