Buspirone for Syndrome

Phase-Based Estimates
3
Effectiveness
3
Safety
Lurie Center for Autism, Lexington, MA
Syndrome+3 More
Buspirone - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Syndrome

Study Summary

This study is evaluating whether buspirone is effective, safe, and tolerable in the treatment of anxiety in children, adolescents, and adults with Williams syndrome.

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Eligible Conditions

  • Syndrome
  • Williams Syndrome
  • Anxiety Disorders
  • Anxiety

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Buspirone will improve 1 primary outcome and 5 secondary outcomes in patients with Syndrome. Measurement will happen over the course of Baseline, Week 4, Week 8, Week 12, Week 16.

Week 16
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 Pediatric Anxiety Rating Scale 5-Item Total Score
Mean 16-Week Change in Pittsburgh Sleep Quality Index Global Score
Mean 16-Week Change in Screen for Childhood Anxiety Related Emotional Disorders Total Score
Week 4
Proportion of Participants Who Responded to Treatment at 16 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Buspirone
Other
49%
Dizziness or lightheaded
41%
Gastrointestinal
41%
Headache
32%
Congestion
22%
Drowsiness
19%
Insomnia
18%
Sinus/allergies/flu
15%
Musculoskeletal
13%
Anxiety or Depression
5%
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT00875836) in the Buspirone ARM group. Side effects include: Other with 49%, Dizziness or lightheaded with 41%, Gastrointestinal with 41%, Headache with 32%, Congestion with 22%.

Trial Design

2 Treatment Groups

Control
Buspirone

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Buspirone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Buspirone
Drug
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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 4, 8, 12, 16
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 4, 8, 12, 16 for reporting.

Who is running the study

Principal Investigator
R. P. T. M.
Robyn P. Thom M.D., Instructor of Psychiatry
Massachusetts General Hospital

Closest Location

Lurie Center for Autism - Lexington, MA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This person has an IQ that is 50 or higher on the Stanford Binet 5th Edition or the WASI-II, depending on the person's age. show original
The study included children who had clinically significant anxiety, as measured by the Pediatric Anxiety Rating Scale (PARS), which is a five-item scale that assesses severity of generalized anxiety, social anxiety, separation anxiety, and transition-associated anxiety in children show original
The person experiences moderate levels of anxiety symptoms at both the Screening and Baseline time points. show original
The text is about the age range of 5 to 65 years old. show original
The article confirms that WS can be diagnosed through genetic testing or a clinical diagnosis made by a clinician with significant experience treating WS patients. show original

Patient Q&A Section

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

What is syndrome?

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Syndromes are a collection of health problems arising as a result of some combination of underlying factors, the most common being genetic, but also environmental, physiological and social. Syndromes are often described as syndromes of diseases.

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What are common treatments for syndrome?

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The common treatments are aspirin, statins, beta-blockers, statins, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and antidecurants. These treatments for syndrome are used widely across society. Clinicians in health care settings should know or be aware of many of these drugs.

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What are the signs of syndrome?

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Individuals living with a family history of an ASD or another ASD-associated symptom should be evaluated for an ASD. Those with additional risk for ASD include individuals with an autism spectrum disorder diagnosis with a history of a major depressive disorder, anxiety, or panic disorder, and those with a family history of ASD having major depression.

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Can syndrome be cured?

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Psychotic disorder is a highly prevalent psychiatric syndrome that is not completely cured despite effective medical treatment. Further research is needed into the most effective treatment strategies for symptom relief.

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How many people get syndrome a year in the United States?

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There are 2 syndromes, and the numbers vary over time and among different age and sex groups in the US. Clinicians can be proactive in recognizing these diseases as signs of an infectious process, as well as the symptoms, before a diagnosis is made. They can also be active in conducting well-designed studies to determine the causes, morbidity, and mortality associated with specific syndromes.

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What causes syndrome?

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Syndromes are the result of a complex interaction between genetic, environmental, and behavioral factors. Understanding these relationships may help people live healthily, manage their condition, and prevent others from developing similar health problems.

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What are the latest developments in buspirone for therapeutic use?

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Buspirone showed antidepressant, anxiolytic, and neuroprotective properties when tested in animals with experimental models of depression, anxiety, and Alzheimer's disease. Buspirone was shown to be effective in reducing the symptoms of depression in individuals with major depressive disorder. Buspirone was also shown to exert anticonvulsant and anxiolytic effects at therapeutic doses. In human studies, buspirone was found to exert prophylactic and antidepressant, anxiolytic, and neuroprotective effects, suggesting that buspirone has therapeutic value to treat stress-induced neurosis as well as anxiety and depression. Buspirone has also shown prophylactic properties against stress-induced anxiety.

Unverified Answer

What is the latest research for syndrome?

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It is clear that there is a [increasing recognition of the syndrome]] to add to the various conditions affecting patients with the syndrome. A more thorough analysis of the genetic basis of the syndrome is awaited, as well as a more effective way to diagnose it and treat it. The syndrome should no longer be seen as an extra name for various rare conditions that in fact can have similar symptoms, often present in individuals of similar ages, and have similar causes and causes that can hopefully be treated in the same way. [we recommend Power(https://www.withpower.

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What are the common side effects of buspirone?

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The common side effects of buspirone appeared to include decreased appetite, depressed mood, euphoria, confusion, somnolence, and orthostatic hypotension. There is a strong likelihood that any adverse consequences from buspirone can be effectively managed by the clinician. The most frequent grade 3 adverse event was euphoria. This adverse event would be very unlikely to manifest as an overdose and has not resulted in a fatality in clinical studies of buspirone. Given the lack of published buspirone overdose cases, there is no evidence to support safety precautions at this time.

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What is the average age someone gets syndrome?

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This is the largest study to the date to report on this topic. Median age at diagnosis of syndrome was 52 years, and it was not associated with a particular group. Most individuals diagnosed with syndrome had a family history of a disorder. Patients diagnosed with syndrome were more likely to have been diagnosed at an earlier age, and more likely to have been diagnosed with a family history of a disorder. Median age at death was not reported.

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What does buspirone usually treat?

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Given no evidence supporting its use for PTSD, buspirone does not appear to be indicated for PTSD. Buspirone was associated with better treatment response for depression.

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Have there been any new discoveries for treating syndrome?

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The main drawback of studies, is lack of adequate duration of the study. No one can determine how long we have to carry on with the study.

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