Phase 3
N=61
Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01972074 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Treatment Responder — 9; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Memantine (Drug); Placebo (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Responder |
9; 4 | — |
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.
Eligibility Criteria
INCLUSION CRITERIA
All Participants:
- Male and female participants, ages 8-17 years (inclusive)
Participants with Autism Spectrum Disorder:
- Meets Diagnostic and Statistical Manual-5 autism spectrum disorder diagnostic criteria, as established by clinical diagnostic interview
- At least moderate severity of social impairment, as measured by a total raw score of ≥85 on the parent/guardian-completed Social Responsiveness Scale, Second Edition (SRS-2) and a score of ≥4 on the clinician-administered Autism Spectrum Disorder Clinical Global Impression-Severity scale (ASD CGI-S)
Healthy Control Participants:
- Age-, sex-, and IQ-matched with participants with autism spectrum disorder 3. No Axis I diagnoses, as established by the Kiddie Schedule for Affective Disorders and Schizophrenia-Epidemiological Version (K-SADS-E) and confirmed by clinical diagnostic interview 4. No significant traits of autism spectrum disorder, as measured by a total raw score of 3 times the Upper Limit of Normal [ULN])
- Participants with genitourinary conditions that raise urine Power of Hydrogen (pH) (e.g., renal tubular acidosis, severe infection of the urinary tract)
- Known hypersensitivity to memantine
- Severe allergies or multiple adverse drug reactions
- A non-responder or history of intolerance to memantine after treatment at adequate doses, as determined by the clinician
- Investigator and his/her immediate family, defined as the Investigator's spouse, parent, child, grandparent, or grandchild.
Data sourced from ClinicalTrials.gov (NCT01972074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.