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Anxiolytic

Buspirone for Anxiety

Phase 4
Waitlist Available
Led By Robyn P Thom, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12, 16
Awards & highlights

Study Summary

This trial will help researchers learn if buspirone is a safe and effective treatment for anxiety in people with Williams syndrome.

Eligible Conditions
  • Anxiety
  • Williams Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12, 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean 16-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score
Secondary outcome measures
Mean 16-Week Change in Child and Adolescent Symptom Inventory Anxiety-Modified Score
Mean 16-Week Change in Each Subscale of the Aberrant Behavior Checklist
Mean 16-Week Change in Pittsburgh Sleep Quality Index Global Score
+2 more

Side effects data

From 2016 Phase 4 trial • 175 Patients • NCT00875836
49%
Other
41%
Dizziness or lightheaded
41%
Gastrointestinal
32%
Headache
22%
Congestion
19%
Drowsiness
18%
Insomnia
15%
Sinus/allergies/flu
13%
Musculoskeletal
5%
Anxiety or Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Buspirone
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: BuspironeExperimental Treatment1 Intervention
Subjects will receive buspirone 2.5 mg each morning at the start of the trial. The dose will be increased by 2.5 mg per week in two divided doses daily depending on effectiveness and tolerability. The optimal dose will be reached by week 12 of treatment. The minimum starting dose will be 2.5 mg and the maximum total daily dose will be 30 mg. Medication will be dosed twice daily due to the short half-life (2-3 hours) of this medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,335 Total Patients Enrolled
25 Trials studying Anxiety
3,511 Patients Enrolled for Anxiety
Robyn P Thom, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Buspirone (Anxiolytic) Clinical Trial Eligibility Overview. Trial Name: NCT04807517 — Phase 4
Anxiety Research Study Groups: Buspirone
Anxiety Clinical Trial 2023: Buspirone Highlights & Side Effects. Trial Name: NCT04807517 — Phase 4
Buspirone (Anxiolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04807517 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial accommodating?

"Correct. Supporting documentation on clinicaltrials.gov affirms that this study, which was originally posted in August 1st 2021, is currently recruiting participants. A total of 20 people need to be admitted from a single research facility."

Answered by AI

Could you provide a synopsis of past experiments conducted with Buspirone?

"Presently, there are 9 trials researching the effects of Buspirone with 0 studies in their third stage. The majority of these medical experiments take place in Tianjin but other cities across China have clinical trials involving this drug as well."

Answered by AI

Are any more volunteers needed for this research endeavor?

"According to the data on clinicaltrials.gov, this experiment is recruiting participants as of now. It was posted initially on August 1st 2021 and its details were updated most recently on July 26th 2022."

Answered by AI

How can I register for this experiment in medicine?

"This medical study is seeking 20 individuals with Williams Syndrome, aged between 5 and 65 years old. To be accepted into the trial, applicants must demonstrate a clinical diagnosis of WS confirmed by genetic testing or an expert clinician; scores on The Pediatric Anxiety Rating Scale (PARS) indicating clinically significant levels of anxiety as well as a Clinical Global Impression Severity Item score for their symptoms ≥ 4 at Screening and Baseline."

Answered by AI

Is Buspirone a dependable option for mitigating adverse symptoms?

"There is an abundance of evidence supporting the safety of Buspirone, thus it receives a rating of 3. As this treatment has passed Phase 4 trialling, its efficacy and security have been established."

Answered by AI

Is there an upper age limit for applicants to this trial?

"The current protocol requires patients to be between the ages of 5 and 65. The database of clinical trials indicates that there are 522 studies available for those below 18, while older individuals have access to 1426 potential opportunities."

Answered by AI
~5 spots leftby Apr 2025