Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment for social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (fMRI and HMRS) to assess neural functional deficits in adolescents with ASD compared to healthy volunteer adolescents and to assess any effects of memantine therapy on neural function in adolescents with ASD. The investigators hypothesize that short-term memantine monotherapy will be safe, well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in adolescents with ASD. Additionally, the investigators hypothesize that following memantine therapy, ASD subjects will exhibit a decrease in glutamate (Glu) concentration in the anterior-cingulate cortex (ACC) and a change towards normalization in altered functional connectivity of the ACC and medial temporal lobes, consistent with improvement in social impairments in ASD. The investigators hypothesize that compared to healthy volunteer subjects, ASD subjects will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between ASD and healthy volunteer neuroimaging data will decrease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder|
- Social Responsiveness Scale-Second Edition (SRS-2) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]The Social Responsiveness Scale is a 65-item rating scale completed by the parent used to measure the severity of autism spectrum symptoms as they occur in natural settings
- Clinical Global Impression-Improvement (CGI-I) subscale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]The CGI-I is a measure of illness improvement.
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Subjects in the placebo control group will receive a matched placebo pill with no active ingredients. This will be administered twice daily for 12 weeks.
Memantine administered in tablet form twice daily titrated to a maximum dose of 20 mg for 12 weeks
Other Name: Namenda
No Intervention: Control Group
Healthy volunteers will be scanned twice (12 weeks apart) and will receive no intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972074
|Contact: Kristina Conroyemail@example.com|
|Contact: Leah Feinberg, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Kristina Conroy 617-724-7079 email@example.com|
|Contact: Leah Feinberg, BS 617-726-4651 firstname.lastname@example.org|
|Principal Investigator: Gagan Joshi, MD|
|Principal Investigator:||Gagan Joshi, MD||Massachusetts General Hospital|