An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01850355|
Recruitment Status : Recruiting
First Posted : May 9, 2013
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders Anxiety||Drug: Buspirone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
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.
- Reduction in Pediatric Anxiety Rating Scale (PARS) score [ Time Frame: Baseline to 8 weeks ]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 PARS score.
- Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score [ Time Frame: Baseline to 8 weeks ]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 sub scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850355
|Contact: Babora Hoskovafirstname.lastname@example.org|
|Contact: Alexa Pulli, BSemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Barbora Hoskova 617-724-7301 firstname.lastname@example.org|
|Contact: Alexa Pulli, BS 617-726-4651 email@example.com|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|