CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 84 enrolled
Drug / intervention
Memantine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01972074
NCT01972074Phase 3Completed

Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder

Massachusetts General Hospital·interventional·Posted Oct 30, 2013·Updated Jul 1, 2024

In Brief

A Phase 3 clinical trial evaluating Memantine and Placebo for Autism Spectrum Disorder. Completed, enrolled 84 participants across 1 site.

Detailed Summary

This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic resonance imaging \[fMRI\] and hydrogen magnetic resonance spectroscopy \[HMRS\]) to assess neural functional deficits in adolescents with autism spectrum disorder compared to healthy volunteer adolescents. This pre- and post-neuroimaging will also be used to assess any effects of memantine therapy on neural function in adolescents with autism spectrum disorder. 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 autism spectrum disorder. Additionally, the investigators hypothesize that following memantine therapy, adolescents with autism spectrum disorder 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 anterior cingulate cortex and medial temporal lobes, consistent with improvement in social impairments in autism spectrum disorder. The investigators hypothesize that compared to healthy volunteer participants, participants with autism spectrum disorder will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between autism spectrum disorder and healthy volunteer neuroimaging data will decrease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMclean Hospital

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 30, 2013
Enrollment StartFeb 17, 2015
Primary CompletionMay 7, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.7 years ago

Interventions

Memantinedrug

Capsule

Placeboother

Capsule