A Pilot Study 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: NCT03432065|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Anxiety||Drug: Buspirone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Buspirone tablets will be administered twice daily, and will be 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. 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 Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score [ Time Frame: Baseline to 8 Weeks ]The primary outcome measure of efficacy will be assessed by the reduction in anxiety symptom severity as measured by a change from baseline on the Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) scores. Responders are defined as those who demonstrate a >30% reduction on the CASI-Anx.
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): NCT03432065
|Contact: Nina Dallenbach, BSfirstname.lastname@example.org|
|Contact: Elizabeth Noyes, BAemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Nina Dallenbach, BS 617-724-7079 firstname.lastname@example.org|
|Contact: Elizabeth A Noyes, BA 617-726-4651 email@example.com|
|Principal Investigator:||Atilla Ceranoglu, MD||Massachusetts General Hospital|