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This study was withdrawn due to competing research interests and slow recruitment.
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The main objective of this exploratory 8 week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buspirone | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug | Children with Autism Spectrum Disorders will receive buspirone or matched placebo. 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 till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Pediatric Anxiety Rating Scale (PARS) Score | Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by change from baseline. Responders are defined as ≥30% reduction in the Pediatric Anxiety Rating Scale (PARS). | baseline to 8 weeks |
| Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score | Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by Clinical Global Impression-Anxiety (CGI-Anxiety). Responders are defined as a score of ≤2 on the improvement subscale (i.e., "much" or "very much improved"). | baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gagan Joshi, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Children with Autism Spectrum Disorders will receive buspirone or matched placebo. 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 till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg. |
|
| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |