A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders



Sponsors


Source

Massachusetts General Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No

Is Us Export

Yes


Brief Summary

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 hypotheses for a larger
randomized-controlled trial with explicit hypotheses and sufficient statistical power.

Overall Status

Recruiting

Start Date

2018-08-01

Completion Date

2020-08-01

Primary Completion Date

2020-08-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
Baseline to 8 Weeks

Enrollment

15

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial. During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.

Arm Group Label

Buspirone


Eligibility

Criteria

Inclusion Criteria:

- Male or female participants between 6 and 17 years of age

- DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview

- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL

- Subjects can be taking psychotropic medications if they have been on the medication
for at least 4 weeks prior to initiating study treatment and if they are on a stable
dose, provided the medication is not listed in the Concomitant Medications section of
the protocol.

Exclusion Criteria:

- 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:

- Pregnant or nursing females

- Organic brain disorders

- Uncorrected hypothyroidism or hyperthyroidism

- Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)

- History of renal or hepatic impairment.

- Clinically unstable psychiatric conditions or judged to be at serious suicidal risk

- Current diagnosis of schizophrenia or bipolar disorder

- History of substance use (except nicotine or caffeine) within past 3 months or urine
drug screen positive for substances of abuse

- Current treatment with medication with primary central nervous system activity (as
specified in the Concomitant Medication section of the protocol)

- A non-responder or history of intolerance to buspirone, after treatment at an adequate
dose and duration as determined by the clinician

- Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers
or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole,
or rifampin.

Gender

All

Minimum Age

6 Years

Maximum Age

17 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Atilla Ceranoglu, MD
Principal Investigator
Massachusetts General Hospital

Overall Contact

Last Name

Nina Dallenbach, BS

Phone

617-724-7079

Email



Location

Facility

Status

Contact

Massachusetts General Hospital
Boston Massachusetts 02114 United States
Recruiting
Last Name: Nina Dallenbach, BS
Phone: 617-724-7079
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Massachusetts General Hospital

Investigator Full Name

Tolga A Ceranoglu

Investigator Title

Medical doctor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Intervention Browse

Mesh Term

Buspirone


Arm Group

Arm Group Label

Buspirone

Arm Group Type

Experimental

Description

Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Elizabeth Noyes, BA

Phone

617-726-4651

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

February 6, 2018

Study First Submitted Qc

February 7, 2018

Study First Posted

February 13, 2018

Last Update Submitted

August 14, 2018

Last Update Submitted Qc

August 14, 2018

Last Update Posted

August 16, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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