Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
|ClinicalTrials.gov Identifier: NCT01972074|
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Drug: Memantine Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder|
|Actual Study Start Date :||February 17, 2015|
|Actual Primary Completion Date :||May 7, 2018|
|Actual Study Completion Date :||May 7, 2018|
Participants in the placebo arm will receive placebo (no active ingredients) in capsule form twice daily. It will be administered twice daily for 12 weeks. Participants will undergo neuroimaging before and after the 12-week treatment phase.
Other Name: Namenda
Placebo Comparator: Placebo
Participants in the memantine arm will receive memantine in capsule form twice daily. It will be administered twice daily for 12 weeks (including a 4-week titration phase to a maximum dose of 20 mg per day). Participants will undergo neuroimaging before and after the 12-week treatment phase.
No Intervention: Control Group
Healthy controls will undergo neuroimaging twice (12 weeks apart) and will receive no intervention during the 12-week window.
- Treatment Responder [ Time Frame: 12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]) ]Treatment responders are defined as having a 25% reduction, from baseline to endpoint, in Social Responsiveness Scale, Second Edition: School-Age, Parent Report (SRS-2) total raw score and an Autism Spectrum Disorder Clinical Global Impression-Improvement (ASD CGI-I) score ≤2. The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item rating scale completed by the parents/guardians of children ages 4-18. It is used to measure the severity of autism spectrum disorder symptoms. Each item is rated on a 4-point Likert scale, ranging from 1=Not True to 4=Almost Always True. Higher scores indicate a higher severity of autism spectrum disorder symptoms. The Autism Spectrum Disorder Clinical Global Impression-Improvement subscale (ASD CGI-I) is a clinician-rated measure of the improvement of autism spectrum disorder symptoms. The subscale is rated on a 7-point Likert scale, ranging from 1=Very Much Improved to 7=Very Much Worse. Higher scores indicate less symptom improvement.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972074
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|