Adults 5 to 65, any sex, with Williams Syndrome or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean 16-Week Change in Pediatric Anxiety Rating Scale 5-Item Total ScorePrimary· Baseline, Week 4, Week 8, Week 12, Week 16; Change from Baseline to Week 16 reported
The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges from 0-25 with higher scores indicating more severe anxiety symptoms. Mean change was estimated using a repeated measures linear regression model with time in categories as the covariate and all non-missing scores for all measurement times as outcomes. A linear contrast estimated mean change between Baseline and Week 16.
Group
Value
95% CI
Buspirone
-7.9
-10.0 – -5.9
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)Secondary· 16 weeks
The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scales indicating improvement (1=very much improved; 2=much improved). In this study, the CGI-I will be focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 will be classified as responders.
Group
Value
95% CI
Buspirone
1.00
0.82 – 1.00
Mean 16-Week Change in Child and Adolescent Symptom Inventory Anxiety-Modified ScoreSecondary· Baseline, Week 4, Week 8, Week 12, Week 16; Change from Baseline to Week 16 reported
The Child and Adolescent Symptom Inventory (CASI) is a caregiver completed questionnaire with items that map directly onto Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for anxiety disorders in children and adolescents. The CASI-Modified which includes 20 specific items that have been used to assess anxiety in subjects with developmental disabilities will be administered. Total score ranges from 0-20 with higher scores indicating more severe anxiety symptoms. Mean change was estimated using a repeated measures linear regression model with time in categories as the c
Group
Value
95% CI
Buspirone
-8.9
-12.8 – -4.9
Mean 16-Week Change in Screen for Childhood Anxiety Related Emotional Disorders Total ScoreSecondary· Baseline, Week 4, Week 8, Week 12, Week 16; Change from Baseline to Week 16 reported
The Screen for Childhood Anxiety Related Emotional Disorders (SCARED) includes both a child/self-report and parent-report form, each containing 41-items. It is used to screen for symptoms of panic disorder, separation anxiety disorder, social phobia, generalized anxiety disorder, and school phobia. Total score ranges from 0-82 and a total score of 25 or greater may indicate the presence of an anxiety disorder. Mean change was estimated using a repeated measures linear regression model with time in categories as the covariate and all non-missing scores for all measurement times as outcomes. A l
Child/self-report form
Group
Value
95% CI
Buspirone
-16.0
-28.1 – -3.9
Parent-report form
Group
Value
95% CI
Buspirone
-9.3
-13.4 – -5.1
Mean 16-Week Change in Each Subscale of the Aberrant Behavior ChecklistSecondary· Baseline, Week 4, Week 8, Week 12, Week 16; Change from Baseline to Week 16 reported
The Aberrant Behavior Checklist (ABC-2) is a caregiver rated instrument that measures psychiatric symptoms and behavioral disturbance in subjects with developmental disability with 5 subscales. Each of its 58 items is scored on a 4-point scale (0=never a problem to 3=severe problem). The 5 subscales and their range of scores are: Irritability 0-45, with higher scores indicating more severe irritability; Social Withdrawal/Lethargy 0-48, with higher scores indicating more severe social withdrawal; Stereotypy 0-21, with higher scores indicating more severe stereotypy; Hyperactivity 0-48, with hig
Irritability
Group
Value
95% CI
Buspirone
-6.3
-10.3 – -2.4
Social withdrawal/lethargy
Group
Value
95% CI
Buspirone
-3.6
-6.1 – -1.0
Stereotypy
Group
Value
95% CI
Buspirone
-1.8
-3.0 – -0.6
Hyperactivity
Group
Value
95% CI
Buspirone
-6.2
-9.4 – -2.9
Inappropriate speech
Group
Value
95% CI
Buspirone
-0.8
-1.7 – 0.1
Mean 16-Week Change in Pittsburgh Sleep Quality Index Global ScoreSecondary· Baseline, Week 4, Week 8, Week 12, Week 16; Change from Baseline to Week 16 reported
The Pittsburgh Sleep Quality Index (PSQI) questionnaire that will be completed by the subject's caregiver to assess sleep quality. The global score ranges from 0-21, where a higher score indicates greater sleep difficulty. Mean change was estimated using a repeated measures linear regression model with time in categories as the covariate and all non-missing scores for all measurement times as outcomes. A linear contrast estimated mean change between Baseline and Week 16.
Group
Value
95% CI
Buspirone
-1.4
-2.3 – -0.5
Adverse events — posted to ClinicalTrials.gov
Time frame: The earlier of 16 weeks or study discontinuation.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to do a preliminary assessment of whether buspirone is effective, safe, and tolerable in the treatment of anxiety in children, adolescents, and adults with Williams syndrome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 3 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04807517.