Trial Outcomes & Findings for An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders (NCT NCT01850355)
NCT ID: NCT01850355
Last Updated: 2025-02-25
Results Overview
The PARS is a clinician-rated scale to be used with parents and children. It consists of 57 items and has two sections: a symptom checklist (first 50 items) and severity items (last 7 items). The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7 severity items are used to determine severity of symptoms and the PARS total score. The total score for the PARS is derived by summing the 7 severity items; total score ranges from 0 to 35, where higher scores indicate greater severity. The outcome reported reflects the change from baseline in PARS scores. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
COMPLETED
NA
9 participants
Baseline to week 8
2025-02-25
Participant Flow
Participant milestones
| Measure |
Participants Ages 6-17
Participants ages 6-17 with autism spectrum disorders and anxiety enrolled to receive treatment with buspirone
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Participants Ages 6-17
n=9 Participants
Participants ages 6-17 with autism spectrum disorders and anxiety enrolled to receive treatment with buspirone
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 8Population: Participants who were exposed to study medication for at least two weeks. One participant was not included because they withdrew consent prior to starting treatment.
The PARS is a clinician-rated scale to be used with parents and children. It consists of 57 items and has two sections: a symptom checklist (first 50 items) and severity items (last 7 items). The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7 severity items are used to determine severity of symptoms and the PARS total score. The total score for the PARS is derived by summing the 7 severity items; total score ranges from 0 to 35, where higher scores indicate greater severity. The outcome reported reflects the change from baseline in PARS scores. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
Outcome measures
| Measure |
Participants Ages 6-17
n=8 Participants
Participants ages 6-17 enrolled to receive buspirone treatment
|
|---|---|
|
Change From Baseline in Pediatric Anxiety Rating Scale (PARS)
|
-10.3 change in scale score
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Week 8 (study endpoint)Population: Participants who were exposed to study medication for at least two weeks. One participant was not included because they withdrew consent prior to starting treatment.
The CGI-Anxiety-I is a clinician rated measure of anxiety improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse). This outcome reports the number of participants who scored ≤2 (improved or very much) at study endpoint.
Outcome measures
| Measure |
Participants Ages 6-17
n=8 Participants
Participants ages 6-17 enrolled to receive buspirone treatment
|
|---|---|
|
Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) Scores of Improved or Very Much Improved at Study Endpoint
|
4 participants
|
PRIMARY outcome
Timeframe: Week 8 (study endpoint)Population: Participants who were exposed to study medication for at least two weeks. One participant was not included because they withdrew consent prior to starting treatment.
Treatment responder is defined by a Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) score ≤ 2 (improved or very much improved) and a ≥30% reduction on the Pediatric Anxiety Rating Scale (PARS) from baseline.
Outcome measures
| Measure |
Participants Ages 6-17
n=8 Participants
Participants ages 6-17 enrolled to receive buspirone treatment
|
|---|---|
|
Treatment Responder
|
4 participants
|
Adverse Events
Participants Ages 6-17
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants Ages 6-17
n=8 participants at risk
Participants ages 6-17 enrolled to receive buspirone treatment
|
|---|---|
|
General disorders
Headache
|
37.5%
3/8 • Number of events 5 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
Psychiatric disorders
Irritability
|
37.5%
3/8 • Number of events 3 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
Nervous system disorders
Insomnia
|
25.0%
2/8 • Number of events 3 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 2 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
General disorders
Dizziness
|
12.5%
1/8 • Number of events 2 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
General disorders
Drowsiness
|
12.5%
1/8 • Number of events 2 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 2 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • 8 weeks (from baseline to end of study)
One participant withdrew consent prior to starting treatment and is not included in the adverse event reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place