NCT01850355Completed
An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Source: ClinicalTrials.gov · Last updated 25 Feb 2025
Brief summary (registry, in English)
The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 22 Apr 2013
- Start date
- Jul 2013
- Primary completion date
- Dec 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Autism
- NCT number
- NCT01850355
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From Jul 2013 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
- Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.
Other illness
- DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder
- History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
- Organic brain disorders
- History of renal or hepatic impairment
- Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
- History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
- A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
Lab values
- Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
Other
- I.Q. \< 70
- Pregnant or nursing females
- Uncorrected hypothyroidism or hyperthyroidism
- Current diagnosis of schizophrenia
Who the study is looking for
- Male or female participants between 6 and 17 years of age
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview
- Participants with a score of ≥13 on the Pediatric Anxiety Rating Scale (PARS)
- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL and CGI-Anxiety severity of ≥ 4
- Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
- Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.