An Open-Label Trial of Buspirone for the Treatment of Anx... | NCT01850355

NCT01850355

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Buspirone	Experimental	Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.	Drug: Buspirone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buspirone	Drug	Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial (dose maintenance pahe). During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Pediatric Anxiety Rating Scale (PARS)	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).	Baseline to week 8
Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) Scores of Improved or Very Much Improved at Study Endpoint	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.	Week 8 (study endpoint)
Treatment Responder	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.	Week 8 (study endpoint)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants between 6 and 17 years of age
Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview
Participants with a score of ≥13 on the Pediatric Anxiety Rating Scale (PARS)
Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL and CGI-Anxiety severity of ≥ 4
Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria

Exclusion Criteria:

I.Q. < 70
DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder
History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
Pregnant or nursing females
Organic brain disorders
Uncorrected hypothyroidism or hyperthyroidism
Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
History of renal or hepatic impairment
Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
Current diagnosis of schizophrenia
History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.

Name	Affiliation	Role
Gagan Joshi, MD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

ID	Title	Description
FG000	Participants Ages 6-17	Participants ages 6-17 with autism spectrum disorders and anxiety enrolled to receive treatment with buspirone

Baseline Characteristics Module

ID	Title	Description
BG000	Participants Ages 6-17	Participants ages 6-17 with autism spectrum disorders and anxiety enrolled to receive treatment with buspirone

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Pediatric Anxiety Rating Scale (PARS)

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).

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.

Posted

Mean

Standard Deviation

change in scale score

Baseline to week 8

ID	Title	Description
OG000

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Participants Ages 6-17	Participants ages 6-17 enrolled to receive buspirone treatment

ID	Term
D000067877	Autism Spectrum Disorder
D001008	Anxiety Disorders
D002659	Child Development Disorders, Pervasive

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D013141	Spiro Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals