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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 4, 8, 12, 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 16
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 moreSide effects data
From 2016 Phase 4 trial • 175 Patients • NCT0087583649%
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
2,946 Previous Clinical Trials
13,204,604 Total Patients Enrolled
25 Trials studying Anxiety
3,489 Patients Enrolled for Anxiety
Robyn P Thom, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have moderate anxiety symptoms, as determined by a doctor's evaluation.You have been diagnosed with certain mental health conditions like OCD, posttraumatic stress disorder, major mood disorder, psychotic disorder, or substance use disorder. These conditions are excluded because they require specific treatments that could make it difficult to accurately assess the effects of the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Buspirone
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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